FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
Labeling: Incorrect or Missing Lot and/or Exp Date
Philips Medical Systems Nederland B.V. recalled five Biplane OR Tables on September 3, 2025, due to potential failure of internal components. The recall affects models 722020 and 722025, distributed worldwide. Users must stop using the affected devices immediately to avoid operational issues.
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter
The recall involves Allura Xper FD20 Biplane OR Tables with product codes 722020 and 722025. The devices have associated 510(k) numbers including K102005 and K130842. They were sold worldwide, including the US, and the quantity recalled is five units.
The systems may fail to perform as intended due to the deterioration of internal components such as the CMOS battery, hard disk drive, and power supply unit. If this occurs, motorized movements will become unavailable.
No specific incidents or injuries have been reported related to this recall, but the potential for operational failure poses a high risk.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact Philips Medical Systems for further guidance.
For more information on the recall, visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2629-2025. Alternatively, contact Philips Medical Systems Nederland B.V.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.