First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
FDA device recall Z-2247-2024 · posted 2024-07-01 · Open, Classified
Recall details
- Recalling firm
- First Source Inc
- Reason for recall
- Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
- Action taken
- Consignees were emailed an URGENT: MEDICAL DEVICE RECALL notification, dated 5/29/24. The notice instructs consignees to follow the recommended preventive maintenance schedule and visually check the device before use to identify if the affected bolt is coming loose. The recalling firm is currently testing a spring clip which will keep the bolt from falling out and will send this part to customers at no charge once approved. Consignees are asked to return the provided response form. Consignees with any questions can contact the firm by email at support@fsimed.com or by phone at 1-800-349-5980 (option 2) from 9:00 AM to 5:00 PM EST from Monday through Friday.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 137 units
- Distribution
- 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.
- Date initiated
- 2024-05-09
- Date posted
- 2024-07-01
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System (K221081) | First Source, Inc. | 2022-06-13 |