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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Fresenius Kabi is emphasizing instructions for large volume parenteral (LVP) programming duration in the Ivenix Infusion System software. 30 units were distributed nationwide.
Philips is recalling 38 Allura Xper FD10C medical imaging systems in which the cooling unit drip tray may not be properly installed, potentially allowing coolant to contact electrical components and cause system shutdown.
Medline has recalled Neuro Angio Packs containing B. Braun IV and pump administration sets because check valve components may become stuck in open or closed positions, potentially affecting medication delivery.
In limited Allura Xper FD20 X-ray systems, the cooling unit drip tray was not installed or inadequately documented. This creates a potential for coolant to contact electrical components and trigger system shutdown.
Philips is recalling select Allura Xper FD20/20 imaging systems where the cooling unit drip tray may not be installed. If not installed, coolant could contact electrical components and cause system shutdown.
BD Ready-to-Use Hydrophilic Catheters (14 Fr, Straight Tip, Female) are being recalled due to incorrect expiration date labeling. The recall affects 149,310 units distributed in Georgia.
Philips is recalling Azurion diagnostic imaging systems with software versions R2.1.10 and R2.2.10 due to six software defects that may cause system restarts, storage issues, and positioning errors. Approximately 10,466 units distributed worldwide are affected.
Heraeus Medical is recalling PALACOS MV+G pro bone cement due to ampoules that may fail to break properly, preventing product use. Affected units were distributed internationally.
The Halyard organ recovery kit was recalled because the devices are unsuitable for organ transplant.
AVID Medical is recalling the Halyard MINI PLUS KIT SOUTH (Kit Code JACK097-08) because the devices are not suitable for organ transplant procedures. The recall affects 380 units distributed in Florida, Georgia, and Puerto Rico.
AVID Medical recalls 132 units of the Halyard ORGAN RECOVERY OR PACK (Kit Code: LLOG1000-15) due to device unsuitability for organ transplant. The recalled units were distributed nationwide in Florida, Georgia, and Puerto Rico.
Applied Medical Resources is recalling 450 units of Kii Low Profile surgical instruments due to a potential blade obturator assembly defect that could affect surgical performance.
The HFD100 Head Fixation Device's torque screws may crack or separate during surgical use, potentially compromising head stabilization. IMRIS is recalling 122 affected units distributed worldwide.
Meridian Bioscience is recalling Revogene C. difficile diagnostic assays (211 units) due to performance decline that may cause false-negative test results. Affected lots were distributed nationwide and in Italy.
Roche is recalling 1,300 cassettes of the Elecsys Anti-TSHR immunoassay due to inconsistent test results across instrument platforms and lot-to-lot calibrator variability. These issues may cause delayed or incorrect diagnosis and treatment.
Certain Arial 900 MHz wireless call stations (Model CSK200-900MR) may fail to alert users about low battery conditions before the device loses power. Approximately 1,898 affected units were distributed in the US and Canada.
Integra LifeSciences is recalling 5,116 units of the Codman CereLink ICP Sensor Basic Kit due to potential corrosion stains on the included 14-gauge Tuohy needle. The kit is used for intracranial pressure monitoring.
Securitas Healthcare recalled 5,627 Arial 900 MHz Call Stations with a firmware issue that prevents timely low battery alerts to the wireless emergency call system.
FDA recalls Philips Tempus Pro Patient Monitors because intracranial pressure and bladder pressure measurements have not been tested or validated for accuracy. Healthcare providers using unvalidated measurements could make incorrect clinical decisions.
Siemens LUMINOS Lotus Max and dRF Max fluoroscopy systems with software version VF11 may display incorrect collimation when rapidly switching between organ programs. The defect affects devices with bucky wall stands for mobile detectors.
Philips patient monitors may fail to reconnect to associated devices when moving between wireless access points with rapidly changing signal strength, potentially interrupting patient monitoring.
Sophysa is recalling 105 units of the Pressio 2 ICP Monitoring System due to customer complaints of unexpected rebooting. The malfunction could interrupt critical patient monitoring.
Integra LifeSciences is recalling the Codman Microsensor Basic Kit due to potential corrosion stains on the included 14-gauge Tuohy Needle. This device is used for intracranial pressure monitoring and corrosion could affect its function.
Philips Incisive CT scanners may produce incomplete scans due to an unstable connection inside the floating sensor. Healthcare facilities should not operate affected devices until repair is arranged with the manufacturer.
A software issue in the BD Pyxis ES Enterprise Server may prevent timely updates of patient and medication information. The defect affects 2,079 systems distributed nationwide and in Canada and Bermuda.
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