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Sources: EU EUDAMED, US FDA
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Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard, left; 70-0056 Acu-Loc Dorsal Plate, Standard, Right; 70-0056-S Acu-Loc Dorsal Plate, Standard, Right; 70-0057 Acu-Loc Dorsal Plate, Narrow, Left; 70-0057-S Acu-Loc Dorsal Plate, Narrow, Left; 70-0058 Acu-Loc Dorsal Plate, Narrow, Right; 70-0058-S Acu-Loc Dorsal Plate, Narrow, Right; 70-0331 Divergent Radial Styloid Plate; 70-0331-S Divergent Radial Styloid Plate; 70-0334 Volar Lunate Suture Plate; 70-0334-S Volar Lunate Suture Plate; 70-0335 Dorsal Rim Buttress Plate, Right; 70-0335-S Dorsal Rim Buttress Plate, Right; 70-0336 Dorsal Rim Buttress Plate, Left; 70-0336-S Dorsal Rim Buttress Plate, Left; 70-0337 Dorsal Lunate Plate, Right; 70-0337-S Dorsal Lunate Plate, Right; 70-0338 Dorsal Lunate Plate, Left;
FDA Recall
Open, Classified
·Acumed LLC·Product code HRS·December 19, 2023
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
FDA Recall
Open, Classified
·Stryker Corporation·Product code GCJ·January 14, 2022
Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ".
FDA Recall
Terminated
·Acumed LLC·Product code HRS·June 29, 2007
Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits). Label located on the back of the WPU. Product is labeled in part: "***Invivo Corporation 12601 Research Parkway, Orlando, FL 32826***Made in U.S.A.***REF 3160***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Label located on the bottom of the DCU. Product is labeled in part: ***Invivo Corporation 12601 Research Parkway Orlando, FL 32826 Made in U.S.A.***REF 3160DCU***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Display Controller Unit (DCU) is labeled in part: "***Invivo***PRECESS***". Wireless Processing Unit (WPU) is labeled in part: "***Invivo***". NOTE: WPU AND DCU MAY HAVE THE SAME OR DIFFERENT SERIAL NUMBERS. The radio is responsible for wireless communication between the Wireless Processing Unit and the Display Controller Unit. Precess is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·September 23, 2011
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
FDA Recall
Terminated
·Steris Corporation·Product code FEB·October 7, 2020
Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code BTO·July 9, 2009
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case.
FDA Recall
Terminated
·NxStage Medical, Inc.·Product code KDI·April 14, 2004
AcuSnare Polypectomy Device, Cook Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. The SASM device prefix denotes Soft AcuSnare Mini. The ASM device prefix denotes Acu Snare Mini. Due to the nitinol core wire, the difference between these two products is stiffness of the snare head wire.
FDA Recall
Terminated
·Wilson-Cook Medical Inc·Product code FDI·April 21, 2004
ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number 10032746, 10037592, 10032746, 10037591 or 10038202.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·March 21, 2008
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case.
FDA Recall
Terminated
·NxStage Medical, Inc.·Product code KDI·April 14, 2004
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case.
FDA Recall
Terminated
·NxStage Medical, Inc.·Product code KDI·April 14, 2004
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)
FDA Recall
Terminated
·Edan Diagnostics·Product code MHX·November 17, 2017
Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code FET·June 20, 2016
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units.
FDA Recall
Terminated
·Hospira Inc.·Product code FRN·March 8, 2013
Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·October 15, 2012
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
FDA Recall
Terminated
·Hospira Inc.·Product code FRN·December 7, 2012
Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 925474325, 925654225, 925654325, 925754325, 925754335, and 92M774325. Intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of a hospital or clinic where low-end monitoring systems are needed.
FDA Recall
Terminated
·Smiths Medical PM, Inc. N7·Product code CCK·December 22, 2008
Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
FDA Recall
Terminated
·Hospira Inc.·Product code FRN·December 7, 2012
"***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***". Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization of the MR scanner.
FDA Recall
Terminated
·Invivo Corporation·Product code MWI·August 30, 2010
Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-down and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values which as heart rate and systolic, mean and diastolic pressure. This device acts as the Central Monitor Station, it permits from one (1) to sixteen (16) bedside monitor(s) to be connected simultaneously.
FDA Recall
Terminated
·Vidco, Inc.·Product code MSX·November 8, 2015