Ingenia 3.0T magnetic resonance system patient support floor plate installation defect
Philips is recalling Ingenia 3.0T MRI systems due to incorrect patient support table floor plate installation. Affected healthcare facilities should verify installation status and contact Philips for corrective action.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall for a medical device with a potential mechanical defect. The installation defect of a patient support structure poses a risk of harm, but no reported patient illnesses or injuries have been documented in the source.
Plain-English summary
Philips North America LLC is recalling Ingenia 3.0T magnetic resonance imaging (MRI) systems due to a potential installation defect. The patient support table floor plate may be incorrectly installed on these systems.
These systems have been distributed worldwide, including in the United States and over 100 countries. Hospitals and imaging centers currently using these MRI systems may be affected.
The FDA has classified this as a Class II recall. Philips has notified healthcare facilities of the issue and provided instructions for verification. Healthcare providers should inspect the installation of the patient support table floor plate and contact Philips if corrective action is needed.
The recalled product
- Product
- Ingenia 3.0T, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 1,509
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. 781377
- 781342
- 782103
- UDI-DI 884838009813
- 884838055339
- 884838098299
- Serial No. 42003
- 71336
- 42370
- 71022
- 42368
- 42117
- 42066
- 42052
- 42040
- 42242
- 71399
- 42241
- 42099
- 42126
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 41 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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