Philips CT System Software Update Addresses Nonhazardous Reliability Issues
Philips is updating Extended Brilliance Workspace software to version 4.5.5 to fix nonhazardous reliability issues and improve system functionality.
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 source explicitly describes the issues as 'nonhazardous reliability issues,' which aligns with the rubric for voluntary precautionary recalls or low-risk issues (Score 2).
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is issuing a Field Change Order to update the Extended Brilliance Workspace (EBW) software to version 4.5.5. The EBW is a component of the Computed Tomography X-Ray System, Model #728260, used to produce cross-sectional images of the body.
The update is being performed to address nonhazardous reliability issues. The source text states that these improvements will enhance the overall quality and functionality of the EBW systems.
The recall affects 265 units distributed worldwide, including the United States and various international markets. Healthcare facilities should contact Philips to schedule the software update.
The recalled product
- Product
- Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 265
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 #728260
- Serial #s
- 12876
- 13924
- 13994
- 13996
- 14104
- 14116
- 14677
- 14682
- 14694
- 14695
- 14702
- 14707
- 14710
- 14727
- 14728
- 14730
- 14824
- 14840
Distribution
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