Reported Apr 19, 2023 · Ongoing
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- DigitalDiagnost C50 1.1-intended for use in generating radiographic
- images of human anatomy Model Number712204
- Lot codes and dates
- UDI-DI(01)00884838095199(21)210159
- USSerial
- Numbers
210034210049210097210182210187210245220002220006220009220020
- OUS
283 of 283 codes
200001200002200005200006200007200009200010200011200012200013200014200015200017200018200019200022200023200024200026200027200028200029200030200031200032200033200034200035200036200037200040200041200042200044200045200046200047200048200049200050200051200052200053200055200056200058200063200064200067200068210001210002210003210004210005210006210007210008210009210010
- Amount recalled
- 10 units US; 283 units OUS
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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