wDR 2.2 Mobile Digital Diagnostic X-Ray System
FDA device recall Z-2045-2023 · posted 2023-06-30 · Open, Classified
Recall details
- Recalling firm
- SEDECAL SA
- Reason for recall
- There is a software login in issue that may prevent the user from logging in.
- Action taken
- 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 Service Engineer to visit the site and implement a software solution to resolve the issue.
- Root cause
- Software change control
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 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,
- Date initiated
- 2023-05-23
- Date posted
- 2023-06-30
- Location
- Algete, Spain
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MobileDiagnost wDR 2.2 (K191813) | Sedecal., Sa. | 2019-08-02 |