Philips TruFlight Select PET/CT Uninterruptible Power Supply Recall
Philips is recalling 31 TruFlight Select PET/CT systems because the Uninterruptible Power Supply (UPS) accessory devices may leak battery acid, overheat, or emit fumes.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with a potential for battery acid leakage, overheating, and fume emission, which poses a significant risk of injury or property damage, meeting the criteria for a Severe (Score 4) classification.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 31 units of the TruFlight Select PET/CT 16-slice Computed Tomography X-ray and Diagnostic Imaging systems. The recall involves the Uninterruptible Power Supply (UPS) accessory devices used in conjunction with these systems.
The recall was initiated because the UPS accessory devices may fail, resulting in battery acid leakage, overheating, and/or the emission of fumes. The affected units were distributed worldwide, including the United States (nationwide, including DC and Puerto Rico) and numerous international locations.
Healthcare facilities and consumers should contact Philips Medical Systems (Cleveland) Inc for instructions on how to address the defective UPS accessory devices. The specific model number is 882438, and the affected serial numbers range from 17002 to 17038.
The recalled product
- Product
- TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 31
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 #: 882438
- Serial #s: 17002
- 17003
- 17004
- 17006
- 17007
- 17008
- 17009
- 17011
- 17012
- 17013
- 17014
- 17015
- 17017
- 17018
- 17019
- 17021
- 17022
- 17023
- 17024
Distribution
Part of a larger recall action
This product is one of 35 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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