Philips Medical Systems Nederlands Recall 87978
Description: Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
Philips Medical Systems Nederlands Recall 87978 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1904-2021 |
| Event ID | 87978 |
| Event Description | Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. |
| Product Type | Devices |
| Distribution | Worldwide distribution. US states of: AL, AZ, FL, GA, IL, MA, MO, NJ, OR, and VA; Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico. |
| Quantity | 42 devices |
| Recall Reason | 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. |
| Device Classification | 20210630 |
| Device Code Info | 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 |
| Center Classification Date | 20210621 |
| Recall Initiation Date | 20160623 |
| Recalling Firm | Philips Medical Systems Nederlands |
| Initial Notification | Letter |
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