Moderate FDA (Devices)·Z-0479-2013·Announced 2013-01-02

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.

What this means for you

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 t
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: software-defect
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

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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