Philips Ingenia MRI System Patient Support Table Floor Plate Installation Defect
Philips is recalling 135 Ingenia 1.5T S MRI systems worldwide because the patient support table floor plate may be incorrectly installed, creating a potential safety risk to patients and staff.
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: The device is FDA Class II. Although no illnesses or injuries have been reported, this represents a risk-of-harm product (medical imaging equipment) with a structural installation defect that could potentially cause patient or staff injury.
Plain-English summary
Philips North America LLC is recalling 135 Ingenia 1.5T S Magnetic Resonance (MRI) systems due to a potential defect in the installation of the patient support table floor plate. The affected systems are identified by specific serial numbers and Model No. 781347.
If the floor plate is incorrectly installed, it may create a safety hazard. The defect could potentially lead to equipment instability or injury to patients or hospital staff who operate or are in proximity to the system.
The affected systems were distributed worldwide, including throughout the United States and internationally to more than 180 countries. Patients or healthcare facilities with affected MRI systems should contact Philips North America LLC to verify whether their equipment is included in this recall and to arrange for proper inspection and correction of the floor plate installation.
The recalled product
- Product
- Ingenia 1.5T S, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 135
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. 781347
- UDI-DI 884838068421
- Serial No. 81034
- 81033
- 81015
- 81113
- 81080
- 81103
- 81137
- 81001
- 81003
- 81004
- 81014
- 81007
- 81006
- 81009
- 81010
- 81011
- 81062
- 81020
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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