Philips Ingenuity Flex UPS Accessory Devices Recalled for Battery Acid Leakage
Philips Medical Systems is recalling 23 Ingenuity Flex UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
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 Class II medical device with hazards including battery acid leakage and overheating, which aligns with the rubric criteria for significant injury or property damage reports.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 23 units of Ingenuity Flex Uninterruptible Power Supply (UPS) accessory devices. These devices are used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall involves specific model and serial numbers distributed worldwide, including the United States, DC, Puerto Rico, and numerous international locations.
The recall was initiated because the firm was notified that the failure of these UPS accessory devices may result in battery acid leakage, overheating, and/or emission of fumes. These hazards present a potential risk of chemical exposure and fire.
Healthcare facilities and users of the affected Ingenuity Flex systems should identify the specific model and serial numbers listed in the recall notice. Affected units should be removed from service and the recalling firm should be contacted for instructions on repair or replacement.
The recalled product
- Product
- Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 23
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 #: 728317
- Serial #s: 260002
- 260003
- 340002
- 340003
- 345001
- 345002
- 345003
- 345004
- 345005
- 345006
- 345007
- 345010
- 345012
- 345013
- 345014
- 345016
- 345017
- 345018
- 345022
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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