FDAMarch 9, 2023device

DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

philips north americaphilipsphilips north

UPCs

00884838095199

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204 — Recall Details · AllClear