The Recall Desk
SevereFDA (Devices)·Z-1770-2015·Announced 2015-06-17

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Category
Medical Device — Imaging System Accessory
Hazard
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

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 35 products in this recall →

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