Philips Ingenuity TF PET/MR Systems Recalled for Potential Database Lockup
Philips is recalling 11 Ingenuity TF PET/MR systems because the PET Reconstruction Server database may lock up between scans, though no field issues have been reported.
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 source explicitly states that no actual database lockup issues have been reported in the field, and the hazard is theoretical. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the score is at most 3; given the lack of reported harm and the specific FDA Class II classification for a software/database issue, a score of 2 (Moderate) is appropriate for a voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 11 Ingenuity TF PET/MR Diagnostic Imaging Systems. The recall addresses a potential issue where the PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun.
The company states that no actual database lockup issues have been reported in field-installed systems. The affected units were shipped to New York, Ohio, and Texas, as well as to Finland, Germany, Hong Kong, Japan, the Netherlands, South Korea, Spain, and Switzerland. The specific serial numbers involved are 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014, and 24061.
This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote. Facilities with these systems should contact Philips Medical Systems for further instructions on resolving the potential database lockup issue.
The recalled product
- Product
- Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 11
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 (11)
- M/N 882380
- S/N: 11005
- 11006
- 11007
- 11008
- 11009
- 11010
- 11011
- 11012
- 11013
- 11014 & 24061.
Distribution
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