Philips Brilliance iCT CT Systems Recalled for Software Defects
Philips Medical Systems is recalling 559 Brilliance iCT CT systems due to software issues affecting scan functions and safety features.
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 with software defects affecting safety-critical functions like exam stop and tube overheat, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 559 Brilliance iCT - Model 728306 Computed Tomography X-ray systems. These devices were distributed worldwide, including in the United States, and are running software version 4.1.6.
The recall is due to numerous software issues that affect critical functions, including scan start position, data acquisition, exam stop, tube overheat, memory overflow, and the failure to provide error messages. These defects can impact the length of acquisition and image volume.
Healthcare facilities and users of these systems should contact Philips Medical Systems for instructions on how to address the software issues. The source text does not specify a particular action for consumers, as these are professional medical devices.
The recalled product
- Product
- Brilliance iCT - Model 728306 Computed Tomography X-ray systems
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 559
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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