Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
FDA device recall Z-1203-2023 · posted 2023-03-02 · Open, Classified
Recall details
- Recalling firm
- SEDECAL SA
- Reason for recall
- Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
- Action taken
- Sedecal issued an URGENT MEDICAL DEVICE RECALL notice to its US distributor on 02/06/2023 by email. The notice explained the issue and requested that distributor to warn its customers about the risk of potential erratic movement and provided a list of precautions until the software is installed. Questions may be directed to calidad-clientes@sedecal.com.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 7 units
- Distribution
- US, Argentina, Panama
- Date initiated
- 2023-02-06
- Date posted
- 2023-03-02
- Location
- Algete, Spain
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. (K221803) | Sedecal., Sa. | 2022-07-18 |