Recall Z-2045-2023 ยท IZL System, X-Ray, Mobile
SEDECAL SA
wDR 2.2 Mobile Digital Diagnostic X-Ray System
| Date | Jun 30, 2023 (initiated May 23, 2023) |
| Status | Open, Classified |
| Reason | There is a software login in issue that may prevent the user from logging in. |
| Root cause | Software change control |
| Action | A recall notification letter was mailed to customers in the United States by the US distributor, Philips, beginning May 23, 2023. Customers are advised to take the following actions: 1) To prevent the system from becoming inoperable, do not reboot or log out of your system until Philips has implemented the software correction. 2) Circulate this notice to all users of the device so that they are aware of the issue. 3) Complete and return the response form to Philips promptly and no later than 30 days from receipt. A Philips representative will contact consignees to schedule a time for a Field |
| Quantity | 1061 units |
| Distribution | Distribution throughout United States including Puerto Rico and US Virgin Islands OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, E |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191813 | MobileDiagnost wDR 2.2 Sedecal., Sa., Aug 2, 2019 |