Reported Jul 7, 2021 · Ongoing
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
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?
- Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
- Lot codes and dates
- Model/ Serial Number/UDIN/A System Code System Serial Number Unique Device Identifier (UDI#) 882442 2155 (01)00884838059443(21)2155 882442 2154 (01)00884838059443(21)2154 882442 2166 (01)00884838059443(21)2166 882442 2171 (01)00884838059443(21)2171 882442 2153 (01)00884838059443(21)2153
- Amount recalled
- N/A
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
Why it was recalled
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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