MRI Patient Support Table Floor Plate May Be Incorrectly Installed
Philips is recalling 24 units of the Intera Achieva 1.5T Pulsar MRI System because the patient support table floor plate may be incorrectly installed. Worldwide distribution affected.
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 FDA medical device recall. The patient support table floor plate installation issue is stated as potential ('may be incorrectly installed'), and no injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products without reported injury are classified as High (Score 3).
Plain-English summary
Philips North America is recalling 24 units of the Intera Achieva 1.5T Pulsar Magnetic Resonance (MRI) System. The patient support table floor plate on these systems may be incorrectly installed.
The recalled systems have been distributed worldwide, including throughout the United States and internationally. The specific affected serial numbers are identified in the product information.
Healthcare facilities with affected systems should contact Philips North America to determine whether their system is affected and to receive instructions regarding inspection and corrective action.
The recalled product
- Product
- Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- installation-defect
- structural-defect
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. 781171
- UDI-DI n/a
- Serial No. 11069
- 11024
- 11048
- 11090
- 11049
- 11058
- 11013
- 11036
- 11045
- 11087
- 11061
- 11009
- 11060
- 11044
- 11039
- 11043
- 11020
- 11007
Distribution
Distributed nationwide across the United States.
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