Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. Date(s) of Distribution: 16-SEP-2014 - 04-MAY-2016. System equipment numbers: 64937259 65862117 63304032 63151474 63250793 63303889 63304149 64140063 63855729 63516113 64077887 66407452 66350303 65342973 63210187 63511276; 66923399 66422060 64085323 61099178 64103799 67936786 66730784 66736708 66628236 63883590 64916638 64927462 65345691 66517161 66403768 63218881 67360962 69856976 65258983 66167983 64778594 61655917 65206981 67874859
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips Medical Systems Nederlands
- Reason for Recall:
- Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Product Codes/Lot Numbers:
Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. Date(s) of Distribution: 16-SEP-2014 - 04-MAY-2016. System equipment numbers: 64937259 65862117 63304032 63151474 63250793 63303889 63304149 64140063 63855729 63516113 64077887 66407452 66350303 65342973 63210187 63511276; 66923399 66422060 64085323 61099178 64103799 67936786 66730784 66736708 66628236 63883590 64916638 64927462 65345691 66517161 66403768 63218881 67360962 69856976 65258983 66167983 64778594 61655917 65206981 67874859
Distribution:
Distributed in: US, AL, AZ, FL, GA, IL, MA, MO, NJ, OR, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1904-2021
Related Recalls
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Philips Medical Systems Nederlands
Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as a diagnostic device. The purpose of the MED is to supply power to charge the magnet. MED is abbreviation for Magnet Energize Device
Philips Medical Systems Nederlands
Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electrical shocks to personnel servicing the MED, MDD or connected cabling.
Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.