Magnetic Resonance System patient support table floor plate installation defect
Philips has recalled Intera 1.5T Achieva Nova-Dual MRI systems due to incorrect installation of the patient support table floor plate. The recall affects 20 units distributed worldwide.
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 an FDA Class II medical device recall involving patient support equipment with an installation defect and no reported injuries or hospitalizations. It meets the High severity threshold as a risk-of-harm product without yet-reported injury.
Plain-English summary
Philips North America LLC is recalling 20 Intera 1.5T Achieva Nova-Dual Magnetic Resonance Systems due to incorrect installation of the patient support table floor plate. The affected units are distributed worldwide, including the United States and numerous international locations.
Healthcare facilities and patients with potentially affected equipment should contact Philips or refer to the official FDA recall notice to verify their unit's serial number and receive guidance on corrective action.
The recalled product
- Product
- Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.
- Manufacturer
- Philips North America Llc
- Affected units
- 20
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. 781173
- UDI-DI n/a
- Serial No. 13010
- 13013
- 13028
- 13017
- 13033
- 13058
- 13061
- 13071
- 13056
- 13074
- 13057
- 13044
- 13060
- 13027
- 13067
- 13049
- 13048
- 13043
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.
See all 41 products in this recall →Related recalls
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