ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
FDA device recall Z-3248-2018 · posted 2018-09-25 · Open, Classified
Recall details
- Recalling firm
- Swissray Medical
- Reason for recall
- Possible injury due to movement of the arm, calibration loss and communication loss.
- Action taken
- November 2016, Swissray Medical issued official communication to customers as a Action Notification Report. The manufacturer, Swissray Medical AG, distributed the Work Instructions for the FCO and the Action Notification Report Form to all distributors and service entities who would be performing corrective actions in the field. The Swissray Field Engineer then presented the Report to the customer (end user facility) and communicated with the customer in-person while performing the corrective action on-site. When corrective actions were completed, both the customer and service personnel then sign the Report to confirm that the customer was informed about the corrective action and that corrective action was completed.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KPR
- Quantity affected
- 26 units
- Distribution
- US Nationwide
- Date initiated
- 2016-08-09
- Date posted
- 2018-09-25
- Location
- Hochdorf, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DDRFORMULA AND DDRFORMULA PLUS (K052943) | Swissray Medical AG | 2005-12-15 |