63 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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FoundationOne CDx (F1CDx), RAL-0003 version 31.0
FDA Enforcement
Class II
·Ongoing·Foundation Medicine, Inc.·December 3, 2025
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
FDA Enforcement
Class II
·Ongoing·Jewel Precision Sheet Metal & Machining Co, Inc.·July 2, 2025
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·September 11, 2024
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect,Pack'd, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT. 23. AIC w/Remote Link, Pkgd, Cln Trl, US; Product Code: 0042-0040-CT-L. 24. Optical AIC w/Impella Connect,Pack'd, EU; Product Code: 0042-0040-EU. 25. Optical AIC w/Impella Connect,EU,Loaner; Product Code: 0042-0040-EU-L. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 27. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 28. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 29. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 30. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 31. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 32. AIC w/Impella Connect for ECP; Product Code: 1000432.
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·October 15, 2025
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
FDA Enforcement
Class II
·Ongoing·Jewel Precision Sheet Metal & Machining Co, Inc.·July 2, 2025
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·June 24, 2026
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 100080 and 0048-0045 - Impella CP with SmartAssist -- ***Added 2/20/24*** (10) 4413 and 004413 - Impella 2.5 Set (11) 5040 and 005040 - Impella 2.5 IMC Pump Set EU (12) 5060 and 005060 - Impella 5.0 IMC Pump Set EU (13) 5064 and 005064 - Impella 5.0 IMC Pump Set Canada (14) 1000115 - Impella CP Pump set, APAC (15) 1000211 - Impella 5.5 Smart Assist Set, JP (16) 1000302 - Impella CP with SmartAssist APAC (17) 1000361 - Impella 5.5 Set AU (18) 1000402 - Impella CP Smart Assist Set (19) 0046-0011 - Impella RP Pump Set, EU (20) 0046-0026 - Impella 5.0 Pump Set ROW (21) 0046-0037 - Impella 5.0 Pump Set APAC (22) 0046-0039 - Impella RP Set APAC (23) 004690-AU - Impella 5.0 Pump Set AU (24) 0048-0002 - Impella CP Pump Set, EU (25) 0048-0002-BR - Impella CP Pump Set BR (26) 0048-0004 - Impella CP Pump Set, Canada (27) 0048-0014 - Impella Smart Assist Set, EU (28) 0048-0024-JP - Impella CP Smart Assist Set, JP (29) 0048-0044 - Impella CP Smart Assist Set, Canada (30) 0048-0047- Impella CP Smart Assist Set APAC (31) 005048-JP - Impella 2.5 Pump Set, Japan (32) 005066-JP - Impella 5.0 Pump Set, Japan (33) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (34) 0550-0004 - Impella 5.5 with SmartAssist Set, CA
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·February 21, 2024
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.0 Pump Set ROW (13) 0046-0037 - Impella 5.0 Pump Set APAC (15) 004680-AU - 5.0 Pump Set AU (16) 0048-0002 - Impella CP Pump Set, EU (17) 0048-0002-BR - Impella CP Pump Set BR (18) 0048-0004 - Impella CP Pump Set, Canada (19) 0048-0014 - Impella CP Smart Assist Set, EU (20) 0048-0024-JP - Impella CP Smart Assist Set, JP (21) 0048-0044 - Impella CP Smart Assist Set, Canada (22) 0048-0047 - Impella CP Smart Assist Set APAC (23) 005040 - Impella 2.5 IMC Pump Set EU (24) 005048-JP - Impella 2.5 Pump Set, Japan (25) 005060 - Impella 5.0 IMC Pump Set EU (26) 005064 - Impella 5.0 IMC Pump Set Canada (27) 005066-JP - Impella 5.0 Pump Set, Japan (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA (30) 1000115 - Impella CP Pump set, APAC (31) 1000211 - Impella 5.5 SmartAssist Set, JP (32) 1000302 - Impella CP with SmartAssist APAC (33) 1000361 - Impella 5.5 Set AU (34) 1000402 - Impella CP Smart Assist Set ***Updated March 15, 2024*** The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation: (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (11) 0046-0011 - Impella RP Pump Set, EU (14) 0046-0039 - Impella RP Set APAC
FDA Enforcement
Class I
·Ongoing·Abiomed, Inc.·February 21, 2024
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·September 11, 2024
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·August 28, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-02347996, 423834-Centricity Universal Viewer Zero Footprint / ZFP-02286658, 1407636-Centricity Universal Viewer Zero Footprint / ZFP-02304121, 651240-Centricity Universal Viewer Zero Footprint / ZFP-02173181, 268034-Centricity Universal Viewer Zero Footprint / ZFP-02402520; 3) 2089507-098, JP-310027-Centricity Universal Viewer Zero Footprint / ZFP-02033125; 4) 2089507-109, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095312, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095313, 327750-Centricity Universal Viewer Zero Footprint / ZFP-02184508; 5) 2089507-111, 105468-1-Centricity Universal Viewer Zero Footprint / ZFP-02254840, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-00096090, JP-340111-Centricity Universal Viewer Zero Footprint / ZFP-01275379, JP-275353-Centricity Universal Viewer Zero Footprint / ZFP-02042636; 6) 2089507-112, 3922-25-Centricity Universal Viewer Zero Footprint / ZFP-01290685, 3922-17-Centricity Universal Viewer Zero Footprint / ZFP-00098229, 1503586-Centricity Universal Viewer Zero Footprint / ZFP-21016603, RU0994-Centricity Universal Viewer Zero Footprint / ZFP-02331255; 7) 2089507-114, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-02360229, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225897, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225898, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225904, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01371500, M51725-Centricity Universal Viewer Zero Footprint / ZFP-01300873, M1781854-Centricity Universal Viewer Zero Footprint / ZFP-01553772, 609334-Centricity Universal Viewer Zero Footprint / ZFP-01282257, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-22186138, CMC-Centricity Universal Viewer Zero Footprint / ZFP-01820241, JP-100014-Centricity Universal Viewer Zero Footprint / ZFP-01890709, KW1102-Centricity Universal Viewer Zero Footprint / ZFP-02191178, 59219_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-02327073, QA1114-Centricity Universal Viewer Zero Footprint / ZFP-02306397, SAU1433-Centricity Universal Viewer Zero Footprint / ZFP-01457278, TTSH-CVIS-Centricity Universal Viewer Zero Footprint / ZFP-02041523, NE4651-Centricity Universal Viewer Zero Footprint / ZFP-00038599, NE6703-Centricity Universal Viewer Zero Footprint / ZFP-00038552, NE6731-Centricity Universal Viewer Zero Footprint / ZFP-00038461, NE3006-Centricity Universal Viewer Zero Footprint / ZFP-00038362, NE2196-Centricity Universal Viewer Zero Footprint / ZFP-00038588, NPV738-Centricity Universal Viewer Zero Footprint / ZFP-00038637, NE2031-Centricity Universal Viewer Zero Footprint / ZFP-00038578, NE7405-Centricity Universal Viewer Zero Footprint / ZFP-00038372, NE2162-Centricity Universal Viewer Zero Footprint / ZFP-00038563, NE4878-
FDA Enforcement
Class II
·Ongoing·GE Healthcare·November 13, 2024
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
FDA Enforcement
Class II
·Ongoing·GE Healthcare·October 2, 2024
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·September 15, 2021
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·September 18, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare·September 25, 2024
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·September 11, 2024
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·September 11, 2024
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·March 16, 2022
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·January 25, 2023
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·January 25, 2023