A counterfeited electronic component was identified in the products affected. The component, a data transceiver (transmitter/receiver), is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room, and may disrupt communications on the L-Net run
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
The products may have been stored at temperatures outside their required storage conditions.
Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system ma
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
GE Healthcare
Class I - Dangerous
GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th
Class I - Dangerous
During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
The products may have been stored at temperatures outside their required storage conditions.
Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.
Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Class I - Dangerous
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Class I - Dangerous
Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
TempaDot products may have been mislabeled.
ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Siemens Healthcare Diagnostics
Class I - Dangerous
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Siemens Healthcare Diagnostics
Class I - Dangerous
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 HPV Master Mix reagent that was packaged in four (4) cobas¿ 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina