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Terminated

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

FDA Recall Z-1599-2016 · Posted None

Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeIXW
Date Initiated2016-04-01
Date Terminated2018-07-11
Product Quantity2,062 devices

Reason for Recall

Reports of failure of the device's power supply.

Firm Action

Fujifilm sent an Medical Device Correction letter dated March 22, 2016, via FedEx to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions for turning the unit off when not in use as an interim action. FMSU will conduct a field replacement of the power supply in all installed units. For further questions, please call (888) 385-4633.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944046FUJI COMPUTED RADIOGRAPHY SYSTEMSFujifilm Medical System U.S.A., Inc. · 1995-05-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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