Rochester, NY, US · 3 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IZL | System, X-Ray, Mobile | Class II | Radiology | 2 | 2024-07-03 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class II | Radiology | 1 | 2021-03-24 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-05-09 | Class II | Ongoing | Z-2247-2024 | First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer. | — | Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient. |
| 2024-05-09 | Class II | Ongoing | Z-2246-2024 | First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer. | — | Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient. |