38 results
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29ms
·
Sources: EU EUDAMED, US FDA
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. Computerized Ambulatory Delivery Device
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FPA·December 9, 2022
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
FDA Recall
Open, Classified
·Zyno Medical LLC·Product code FRN·September 13, 2024
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs ECO 30GS Ecogel 100 Ultrasound Grn 1in X 5L Cube 1 Dispenser Btl ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
FDA Recall
Open, Classified
·National Distribution & Contracting Inc·Product code ITX·August 24, 2021
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
FDA Recall
Open, Classified
·Surgical Theater Inc·Product code LLZ·September 16, 2025
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
FDA Recall
Open, Classified
·Surgical Theater Inc·Product code LLZ·September 16, 2025
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
FDA Recall
Open, Classified
·Surgical Theater Inc·Product code LLZ·September 16, 2025
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
FDA Recall
Open, Classified
·Surgical Theater Inc·Product code LLZ·September 16, 2025
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
FDA Recall
Open, Classified
·Surgical Theater Inc·Product code LLZ·September 16, 2025
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
FDA Recall
Open, Classified
·Surgical Theater Inc·Product code SFB·September 16, 2025
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
FDA Recall
Open, Classified
·Surgical Theater Inc·Product code LLZ·September 16, 2025
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024