Medical Devices Recalls

Hazard: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

Hazard: There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

Hazard: There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

Hazard: Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.

Hazard: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

Hazard: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

Hazard: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

Hazard: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

Hazard: Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.

Hazard: There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

Hazard: The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

Hazard: GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices

Hazard: GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices

Hazard: GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices

Hazard: There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.

Hazard: Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.

Hazard: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Hazard: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Hazard: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

Hazard: Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock.

Hazard: Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.

Hazard: Device outer packaging was incorrectly labeled.

Hazard: A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the conditions listed below occur within a few milliseconds timeframe of each other: - The SRM module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the SRM module buffer - There is divert gate malfunction and a narrow timing window Only in this specific scenario, Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without a unique error message being generated. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the pending test orders (not yet performed) on Tube B.

Hazard: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Hazard: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Hazard: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Hazard: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Hazard: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Hazard: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.