Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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

U.S. FDA — Device Enforcement · United States · 2023-01-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1206-2023
Date of alert: 2023-01-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Carestream Health, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 60889978621613

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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