MRI Patient Support Table Floor Plate May Be Incorrectly Installed
Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.
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: An incorrectly installed patient support floor plate on an MRI system poses a risk of patient harm during medical procedures, meeting the criterion for risk-of-harm products where injury has not yet been reported. The FDA Class II classification confirms the product may cause adverse health consequences.
Plain-English summary
The Philips GYROSCAN T5-NT Magnetic Resonance System (Model 78106) is subject to this recall due to a potential installation defect affecting the patient support table floor plate. Approximately 23 units worldwide are impacted.
An incorrectly installed patient support floor plate may affect the stability and safety of the system during patient examinations. This defect has been identified by the manufacturer.
If you operate an affected unit, contact Philips North America LLC to verify the installation status of your system's patient support table floor plate and arrange any necessary corrections. The recall affects healthcare facilities in the United States and over 100 other countries.
The recalled product
- Product
- GYROSCAN T5-NT, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Hazard
- Affected units
- 23
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. 78106
- UDI-DI n/a
- Serial No. 1194
- 1249
- 1009
- 1161
- 1091
- 1130
- 1183
- 1196
- 1260
- 1151
- 1022
- 1126
- 1176
- 1211
- 1238
- 1256
- 1070
- 1233
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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