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

Recall Z-1383-2023 — DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

U.S. FDA — Device Enforcement · United States · 2023-03-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1383-2023
Date of alert
2023-03-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884838095199
Reported risk: If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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