Philips Brilliance iCT SP CT System Software Feature Recall
Philips is recalling 12 Brilliance iCT SP CT systems because the perfusion scan feature may be unavailable on specific software versions.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall addresses a software feature availability issue rather than a physical defect or safety hazard, fitting the criteria for cosmetic or documentation issues.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 12 units of the Brilliance iCT SP Computed Tomography X-ray system. The recall involves specific serial numbers and is distributed worldwide, including the United States and numerous international locations.
The recall is issued because the perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers who previously used the basic axial perfusion software without purchasing the helical perfusion license key were unable to access the basic axial perfusion feature after upgrading to software version 4.1.2.
Affected customers should contact Philips Medical Systems for further instructions regarding the software issue.
The recalled product
- Product
- Brilliance iCT SP Computed Tomography X-ray system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 12
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 (12)
- Model No. 728311
- S/N: 200047
- 200051
- 200067
- 200074
- 200098
- 200127
- 200200
- 200202
- 200203
- 200204
- 200206 & 200209.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Philips Medical Systems (Cleveland) 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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