[Recalled] 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 380-48
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 S |
|---|---|
| Brand / manufacturer | Carestream Health, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1206-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 30 January 2023 |
| EAN / barcode | 60889978621613 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Carestream Health, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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