75 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
FDA Recall
Terminated
·Medivators, Inc.·Product code FKQ·April 20, 2021
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code FKQ·March 1, 2013
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·February 26, 2014
MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.
FDA Recall
Terminated
·Medrad Inc·Product code DXT·May 17, 2010
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
FDA Recall
Terminated
·Medtronic Inc.·Product code MDS·July 15, 2020
ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents.
FDA Recall
Terminated
·Cardinal Health 303 dba Cardinal Health·Product code FRN·December 19, 2008
Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
FDA Recall
Terminated
·Merge Healthcare, Inc.·Product code HKI·December 9, 2016
Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065
FDA Recall
Terminated
·Freedom Designs Inc·Product code IOR·May 14, 2007
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZO·May 8, 2017
MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZP·May 8, 2017
MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZO·May 8, 2017
MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
FDA Recall
Terminated
·Medtronic Inc.·Product code OZP·May 8, 2017
Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·January 18, 2017
Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
FDA Recall
Terminated
·Merge Healthcare, Inc.·Product code HKI·December 9, 2016
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 55, Catalog Number LG-PR0855, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 35, Catalog Number LG-PR0835, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 50, Catalog Number LG-PR0850, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 40, Catalog Number LG-PR0840, Allez Spine, LLC., Irvine, CA
FDA Recall
Terminated
·Allez Spine, LLC·Product code MNI·July 30, 2007