FDA Recall
Open, Classified
Phoenix mKDR, digital mobile diagnostic x-ray system
Recall: Z-1202-2023
·
Initiated February 6, 2023
Recall
- Recall Number
- Z-1202-2023
- Event Number
- 91656
- Firm
- SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain
- FEI Number
- 3002495042
- Product Code
- IZL
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- February 6, 2023
- Posted
- March 2, 2023
Description
Phoenix mKDR, digital mobile diagnostic x-ray system
Reason
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Action
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 [email protected].
Distribution
US, Argentina, Panama
Quantity
53 units