FDA Device recall Z-1206-2023
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…
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of 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… by Carestream Health, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1206-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-30 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carestream Health |
| Distribution | US |
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
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
Identifiers
| code_info | UDI: 60889978621613 (Rayco) 60889978624188 (1049) US Serial Numbers: SP0763 50066 50082 50089 50135 50145 50143 50140D…UDI: 60889978621613 (Rayco) 60889978624188 (1049) US Serial Numbers: SP0763 50066 50082 50089 50135 50145 50143 50140D 50144 OUS serial numbers: SP0819 SP0687G2 SP0726 SP0746 SP0834 SP0837 S0001 S0170 S0698G2 1085 FS0564 S0578 S0744 SP0903 SP0600 SP1035 SP0930 SP1007 SP1037 SP0772 S0934G2 S0639G2 S1020G2 S0118 S0135 S0134 S0165 S0167 S0168 S0181 S0800G2 S0784G2 S0811G2 S0832G2 S0826G2 S0822G2 S1038G2 S0678G2 S0619G2 S0636G2 S0641G2 S0643G2 S0701G2 S0738G2 S0758G2 S0760G2 S0673G2 S0785G2 S0842G2 S0860G2 S0863G2 S0888G2 S0973G2 S1105G2 S1048G2 S1073G2 S1004G2 S1110G2 S0791G2 S0941G2 SP0900 S0625 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2023-11-15 · Carestream Health - Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for exam…
FDA Device · Class II · 2020-01-22 · Carestream Health - OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) T…
FDA Device · Class II · 2019-05-01 · Carestream Health - DRX-Revolution Mobile X-Ray System
FDA Device · Class II · 2017-07-05 · Carestream Health
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1206-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.