First Source Inc: Device Recall
Recall #Z-2247-2024 · 05/09/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2247-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- First Source Inc
- Status
- Ongoing
- Date Initiated
- 05/09/2024
- Location
- Rochester, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 137 units
Reason for Recall
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
Product Description
First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, IL, IN, LA, MA, MD, MI, MO, MS, NC, NY, OK, PA, TN, TX, & VA. The countries of Korea & Serbia.
Other Recalls by First Source Inc
- Class II: Risk 05/09/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.