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.
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 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
- 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. 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.
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