Philips CT System Software Recall for Incorrect Value Display
Philips is recalling 2,580 Extended Brilliance Workspace CT systems to fix a software defect that may display incorrect values.
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 medical device where incorrect values may be displayed, posing a risk of harm to patients through potential diagnostic errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 2,580 units of the Extended Brilliance Workspace (EBW), a component of the Computed Tomography X-Ray System. The EBW is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall covers systems currently running software versions 4.0.2, V4.5.2, or V4.5.3.
The recall is issued to address a number of non-conformances, specifically that incorrect values may be displayed on the system. Philips is providing a software update (version 4.5.5) to resolve these issues.
The affected devices were distributed worldwide, including in the United States and numerous international countries. Healthcare facilities and users of these specific CT system components should contact Philips to obtain the software update.
The recalled product
- Product
- Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 2,580
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 #
- 3467
- 5610
- 6151
- 6204
- 6209
- 6221
- 6437
- 6483
- 6543
- 6636
- 6658
- 6717
- 6788
- 6865
- 7154
- 7186
- 7253
- 7470
Distribution
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