Reported Mar 8, 2023 · Ongoing
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality…
Carestream Health, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carestream Health, Inc. · 1049 W Ridge Rd · Rochester, NY · 14615-2731
Is this the product you have?
- 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 NotePDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC)
- Lot codes and dates
- UDI60889978621613 (Rayco) 60889978624188 (1049)
- US Serial Numbers
SP076350066500825008950135501455014350140D50144
- OUS serial numbers
62 of 62 codes
SP0819SP0687G2SP0726SP0746SP0834SP0837S0001S0170S0698G21085FS0564S0578S0744SP0903SP0600SP1035SP0930SP1007SP1037SP0772S0934G2S0639G2S1020G2S0118S0135S0134S0165S0167S0168S0181S0800G2S0784G2S0811G2S0832G2S0826G2S0822G2S1038G2S0678G2S0619G2S0636G2S0641G2S0643G2S0701G2S0738G2S0758G2S0760G2S0673G2S0785G2S0842G2S0860G2S0863G2S0888G2S0973G2S1105G2S1048G2S1073G2S1004G2S1110G2S0791G2S0941G2
- Amount recalled
- 72 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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