Siemens Recalls 80 ONCOR MRI Systems for Software Update
Siemens Medical Solutions is voluntarily recalling 80 ONCOR MRI systems nationwide to install a software update.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary, firm-initiated action for a software update with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is voluntarily recalling 80 units of the ONCOR Expression, ONCOR Impression, and ONCOR Impression plus MRI systems. The recall was initiated on February 14, 2017, and affects devices distributed throughout the United States. The specific reason for the recall is the need for a software update.
The affected devices are identified by model numbers 7360717, 5857920, and 5857912. Siemens notified customers via letter. The recall was classified as Class II by the FDA and was terminated on December 18, 2017.
The recalled product
- Product
- ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 80
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 (3)
- Device Model# 7360717
- 5857920
- 5857912
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Siemens Medical Solutions USA, Inc 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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