Reported May 6, 2020 · Terminated
Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and…
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 · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the
- following clinical application areasvascular, non-vascular, cardiovascular and neuro procedures
- Lot codes and dates
- Serial Numbers
81 of 81 codes
709710711713716715439526637653684621497792595674737628429605895540769668697758633520738691813428590706611655804663588877854654488836689717790629598736810841946795673776645646703608
- System Equipment Numbers
81 of 81 codes
746204477462043774613625746135387462034177839007733405837332670177646555775599777797094877427180727220667913260472273457761000487797080074620302728058597722862380018072746119617764701475486269782489287548635776888124755815717824362275423992779710157481754976890243743520127726021077213972789933567734758575532686791523787910911875533239745362137915225477838972781500207869615877559984764818407584818179112403779058318017186579042710776970967721397074778339747788977305185773717291
- Serial Numbers
- Amount recalled
- 162 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose..
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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