Siemens MAGNETOM MRI Systems Recalled Due to Magnetic Table Cover Hazard
Siemens is recalling eight MAGNETOM Aera/Skyra MRI systems because the patient table's docking station cover may contain a magnetic plate that attracts to the main magnet.
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 recall involves a risk-of-harm product where the magnetic attraction could interfere with equipment operation, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling eight MAGNETOM Aera/Skyra whole body magnetic resonance imaging (MRI) systems. The specific component involved is the docking station top cover (part no# 10591430) of the removable patient table. The affected model numbers are 10432914 and 10432915.
The recall was initiated because the docking station top cover may contain a magnetic metal plate. When the patient table is being docked or undocked, this magnetic top cover may become attracted to the main magnet of the MRI system. This attraction could potentially interfere with the safe operation of the table.
The affected units were distributed nationwide to facilities in Ohio, Florida, Tennessee, Minnesota, New York, and Virginia. The specific serial numbers for the eight affected systems are 42472, 42489, 42477, 46169, 46178, 46175, 42478, and 42485. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this issue.
The recalled product
- Product
- MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — MRI Systems
- Affected units
- 8
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 (8)
- Model # 10432914 and 10432915 Serial Numbers: 42472
- 42489
- 42477
- 46169
- 46178
- 46175
- 42478
- 42485
Distribution
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