St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
Beckman Coulter
Class I - Dangerous
There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
Class I - Dangerous
Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.
GIZA Vertebral Body Replacement
Eden Spine Europe SA
Class I - Dangerous
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
ARIES System and ARIES M1 System
Luminex
Class I - Dangerous
The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Abbott Medical Optics Inc. (AMO)
Class I - Dangerous
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Healon Pro, Part No. 10270012
Abbott Medical Optics Inc. (AMO)
Class I - Dangerous
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Class I - Dangerous
Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
Medi-Therm Hyper/Hypothermia System, MTA7900
Stryker Medical Division of Stryker
Class I - Dangerous
The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode.
Healon 5 Pro, Part No. 10270015
Abbott Medical Optics Inc. (AMO)
Class I - Dangerous
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Abbott Medical Optics Inc. (AMO)
Class I - Dangerous
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Abbott Medical Optics Inc. (AMO)
Class I - Dangerous
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Class I - Dangerous
This lot of left plates were laser etched and packaged as right plates.
Healon V, Part No. 10290045
Abbott Medical Optics Inc. (AMO)
Class I - Dangerous
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Bone Dowell Harvest Tubes
Zimmer Biomet
Class I - Dangerous
mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
Savaria SL-1000 Stairlift
Savaria Concord Lifts
Class I - Dangerous
The electrical controller, combined with motor, causes feedback, damaging a component on the control board, starting a fire.
Class I - Dangerous
When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitting on an over inflated or under inflated Sensor Ready Cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.