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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Philips Ingenia Ambition S MR systems with software versions R11.1 or R12.1 may display incorrect tissue stiffness values when viewing MR Elastography data on PACS. Incorrect values could affect clinical interpretation.
A Siemens fluoroscopic X-ray system software issue may prevent ortho images from flipping and could display a previous patient's image. The recall affects 41 units distributed in the US and several other countries.
Philips Evolution Upgrade 1.5T MR systems may display inaccurate stiffness values from MR Elastography scans when viewed in PACS, potentially affecting clinical interpretation.
Aju Pharm Co., Ltd. is recalling 1,088 units of the Fixone Biocomposite Anchor due to reports of device failures including breakage, bending, and pullout. No injuries have been reported.
Miach Orthopaedics is recalling 284 units of the BEAR Implant Model 1000 due to an incorrect expiration date on the label that extends beyond the product's documented shelf life. The incorrect label date also makes the UDI incorrect.
Medline HEAD SHAVE-LATEX SAFE KIT kits are being recalled due to complaints that the MASTISOL liquid adhesive tubing cracks during use, potentially causing adhesive leakage.
Medline medical procedure convenience kits containing MASTISOL liquid adhesive are recalled due to reports that the butyrate tubing in the adhesive vials cracks during use. Approximately 857 units were distributed nationwide.
Philips is recalling Ingenia 3.0T MR systems that may display incorrect stiffness values when viewing exported MR Elastography maps in PACS viewers, potentially affecting clinical diagnostic accuracy.
Aju Pharm Co., Ltd. is recalling Genesis Knotless Anchor surgical devices due to reports of device failure, including anchor breakage, bending, and pullout. The recall affects 1,163 units distributed in California and Puerto Rico.
Philips is recalling Ingenia Elition X MRI systems due to potential errors in stiffness measurements displayed in elastography imaging. Affected users should verify measurement accuracy with clinical engineers.
Cerapedics, Inc. recalls 237 PearMatrix P-15 bone graft units (lot 7014819) due to incorrect expiration date labeling. Patients should contact their surgeon; facilities should quarantine remaining inventory.
Philips Evolution Upgrade 3.0T MR systems with software versions R11.1 and R12.1 may display inaccurate stiffness values in MR elastography images viewed in PACS, potentially affecting diagnostic accuracy.
Canon Medical's Alphenix interventional x-ray systems may have loose fixing screws in the ceiling movement gear, potentially preventing lateral movement and causing sensor errors. 98 units worldwide are affected.
Zimmer Tourniquet Systems A.T.S. 5000TS with software v2.04 or prior may experience frozen or unresponsive touchscreen displays in certain non-English language settings, potentially delaying access to alternate devices during medical procedures.
Philips SmartPath MR systems with software versions R11.1 and R12.1 may display inaccurate stiffness values when elastography data is exported to PACS viewing systems, potentially affecting measurement accuracy.
Philips is recalling 21 Ingenia Ambition X MR systems due to potential errors in MR Elastography stiffness values when viewing exported data in PACS systems. The inaccurate measurements could affect diagnostic accuracy.
Medline is recalling 1,928 medical procedure convenience kits due to defective tubing in MASTISOL liquid adhesive vials that may crack during use. The kits were distributed nationwide to healthcare facilities.
The FDA has recalled 2,569 units of the AlternatiV+ Max Knotless Anchor due to reports of device failures including anchor breakage, bending, and pull-out. The devices were distributed nationwide.
Aju Pharm recalls Genesis Dual Thread Screw-In Anchors due to reports of device failure including anchor breakage, bending, and pull-out. The recall affects 400 units distributed nationwide in California and Puerto Rico.
GOLD STAR DISTRIBUTION INC is recalling multiple Trojan condom products due to potential rodent exposure detected in the distribution center. Affected products were distributed nationwide, including Minnesota.
The Alphenix INFX-8000C x-ray system's ceiling suspension screws may become loose, preventing lateral movement and causing sensor errors. 172 units distributed in the US and Dominican Republic are affected.
The FDA is recalling AlternatiV+ Screw-In Anchors due to reports of device failure, including breakage, bending, and pull-out. Approximately 416 units were distributed nationwide in California and Puerto Rico.
Medline Industries is recalling NERVE BLOCK TRAY 2 kits (SKU DYNJRA2713) due to complaints that butyrate tubing cracks during use of MASTISOL Liquid Adhesive. Affected kits should not be used.
Philips SmartPath to dStream 3.0T MRI systems with software versions R11.1 and R12.1 may display inaccurate stiffness values when viewing MR Elastography maps in PACS viewers.
Cardinal Health chest drainage units are being recalled because the instructions needed clarification about intended use in adults aged 18+. When used on infants, the units may not show expected visual indicators, potentially leading to improper treatment assessment.
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