PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: April 19, 2023 Initiated: March 9, 2023 #Z-1383-2023

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Philips North America Llc
Units Affected
10 units US; 283 units OUS
Distribution
Nationwide including Puerto Rico and Virgin Islands Foreign: ARGENTINA Australia Austria Bosnia and Herzegovina Bulgaria China Colombia Cyprus Czech Republic Egypt France French Polynesia Germany Greece Hungary Indonesia Italy Jordan Kenya Latvia Lithuania Macedonia Malta Mexico Netherlands New Zealand Philippines Poland Portugal Puerto Rico Russian Federation Saudi Arabia Serbia Slovenia South Africa Spain Sri Lanka Switzerland Tanzania Thailand United Arab Emirates Viet Nam Yemen
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled? ▼
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204. Recalled by Philips North America Llc. Units affected: 10 units US; 283 units OUS.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2023. Severity: Moderate. Recall number: Z-1383-2023.

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