DRX-Compass/DR-FIT X-ray Systems with Firmware version 2 — Class II medical device recall Z-1206-2023
Ongoing recall by Carestream Health, Inc., reported 2023-03-08, distributed nationwide. After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (O
| Recall number | Z-1206-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health, Inc., Rochester, NY, United States |
| Recall initiated | 2023-01-30 |
| Classified | 2023-03-02 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CN, FI, FR, IN, IT, KR, MY, PL |
| Quantity | 72 units |
| UPC / GTIN / UDI-DI | 60889978621613, 60889978624188 |
| Serial numbers | 1085, 50066, 50082, 50089, 50135, 50140D, 50143, 50144OUS, 50145, FS0564, S0001, S0118, S0134, S0135, S0165, S0167, S0168, S0170, S0181, S0578, S0619G2, S0625, S0636G2, S0639G2, S0641G2 and 46 more |
| Model numbers | 8624181 |
Product
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).
Reason for recall
After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury
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-1206-2023. 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.