Recall Z-2246-2024— First Source Inc
Class II · Ongoing
Class II FDA medical device recall by First Source Inc, initiated 2024-05-09. FDA's recall record names no specific 510(k) clearance for this event. Product: First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.. Reason: Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient..
- Recalling firm
- First Source Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-09
- Firm location
- Rochester, NY, United States
Product description
First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
Reason for recall
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.