Reported Oct 3, 2018 · Terminated
INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging…
Philips Electronics North America Corporation
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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
- Lot codes and dates
- All systems with an actuator for the FlexVision Monitor Ceiling Suspension in the period 2003 to May 2011 are affected.
- Amount recalled
- 5115 total
This recall covers 27 products
The agency filed one notice per product. You are reading one of them; the other 26 are below.
14 more are in the archive.
Where it was sold
Why it was recalled
There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the actuator rotor shaft and the monitor falls, there is a risk of injury for the patient, user and bystander.
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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