Philips Ingenia Elition S MRI systems may have incorrectly installed patient support floor plates
Philips North America is recalling 131 Ingenia Elition S magnetic resonance imaging systems due to incorrect installation of the patient support table floor plates.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a structural installation defect on critical patient support equipment. No injuries, illnesses, or hospitalizations have been reported. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 131 units of the Ingenia Elition S Magnetic Resonance System. The patient support table floor plate on these devices may be incorrectly installed.
The affected systems carry Model Numbers 781357 and 782106 and have been distributed worldwide, including throughout the United States and numerous other countries.
Healthcare facilities with affected equipment should contact Philips North America LLC or the U.S. Food and Drug Administration for guidance on verifying proper installation and any corrective measures needed.
The recalled product
- Product
- Ingenia Elition S, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- installation-defect
- patient-safety
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 781357
- 782106
- UDI-DI 884838088108
- 884838098329
- Serial No. 46065
- 46071
- 46077
- 46025
- 46224
- 46005
- 46003
- 46001
- 46008
- 46004
- 46007
- 46032
- 46011
- 46012
- 46013
- 46015
Distribution
Distributed nationwide across the United States.
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