The Recall Desk
HighFDA (Devices)·Z-1780-2015·Announced 2015-06-17

Philips Recalls Ingenuity PET/MR Uninterruptible Power Supply Accessory Devices

Philips Medical Systems is recalling nine Ingenuity PET/MR Uninterruptible Power Supply (UPS) accessory devices due to risks of battery acid leakage, overheating, and fume emission.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (battery acid leakage, overheating, fumes) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling nine units of the Ingenuity PET/MR Uninterruptible Power Supply (UPS) accessory devices. These devices are used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall covers specific units identified by Model # 882380 and Serial #s 11006 through 11014.

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. The affected units were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations.

Consumers and healthcare facilities should identify if they possess the affected serial numbers and contact the recalling firm for instructions on how to proceed with the recall.

The recalled product

Product
Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
9

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 (9)

  • Model #: 882380
  • Serial #s: 11006
  • 11007
  • 11008
  • 11009
  • 11010
  • 11011
  • 11012
  • 11013 & 11014.

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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