Philips MX 16-slice CT System Software Recall for Data Integrity Issues
Philips is recalling 899 MX 16-slice CT systems due to software defects that may cause patient image mix-ups or scan interruptions.
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 recall is classified as FDA Class II, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The software defects primarily affect data integrity and workflow rather than causing direct physical injury, fitting the Moderate severity criteria.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 899 units of the MX 16-slice whole body computed tomography X-ray system. The recall involves specific software version 1.1.4.21426 and affects systems distributed across 18 U.S. states and numerous international countries.
The recall is due to three software issues: first, the image clipboard is not cleared between patients, which may result in previous patient images being pasted onto the current patient's film; second, the Bolus Tracking scan may abort unexpectedly if Auto Voice is enabled, requiring manual restart of the diagnostic scan; and third, the Spiral Auto Start (SAS) option may not display or enable correctly on the first helical scan after system startup.
Healthcare facilities using these systems should contact Philips Medical Systems for instructions on updating the software to resolve these defects.
The recalled product
- Product
- MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 899
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 (1)
- Model No. 728131
Distribution
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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