Magnetic Resonance System patient support table floor plate may be incorrectly installed
Philips Ingenia Ambition X MRI systems may have incorrectly installed patient support table floor plates. This affects 404 units distributed worldwide.
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 potential assembly defect in a patient support table. No injuries or illnesses have been reported. The recall addresses a risk-of-harm scenario where incorrect installation could potentially compromise the stability of the support table during clinical use, fitting the High category per the rubric.
Plain-English summary
Philips North America LLC is recalling the Ingenia Ambition X Magnetic Resonance System due to a potential defect affecting the patient support table floor plate installation.
The patient support table floor plate on some units may be incorrectly installed. The manufacturer has identified this issue and initiated a recall to address it.
A total of 404 Ingenia Ambition X systems are affected by this recall. These systems have been distributed worldwide across the United States and numerous other countries.
Customers and healthcare facilities should contact Philips North America LLC to confirm whether their system is affected and to arrange for inspection or correction of the floor plate installation.
The recalled product
- Product
- Ingenia Ambition X, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- installation-defect
- structural-instability
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. 781359
- 782109
- 782138
- UDI-DI 884838090040
- 884838098350
- 884838108622
- Serial No. 47199
- 47290
- 47387
- 47062
- 47325
- 47038
- 47554
- 47043
- 47004
- 47278
- 47323
- 47027
- 47542
- 47794
Distribution
Distributed nationwide across the United States.
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