First Source Vision M — Class II medical device recall Z-2246-2024
Ongoing recall by First Source Inc, reported 2024-07-10, distributed nationwide. Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
| Recall number | Z-2246-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | First Source Inc, Rochester, NY, United States |
| Recall initiated | 2024-05-09 |
| Classified | 2024-07-01 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | KR, RS |
| Quantity | 680 units |
| Serial numbers | 3009, 3010, 3013, 3014, 3015, 3016, 3017, 3018, 3019, 3020, 3021, 3022, 3023, 3024, 3025, 3026, 3027, 3028, 3029, 3030, 3031, 3032, 3033, 3034, 3035 and 475 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2246-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.