The Recall Desk
HighFDA (Devices)·Z-1772-2015·Announced 2015-06-17

Philips Medical Systems Recalls Ingenuity Core 128 UPS Accessory Devices

Philips Medical Systems is recalling 288 Ingenuity Core 128 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 (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 288 units of the Ingenuity Core 128 Uninterruptible Power Supply (UPS) accessory devices. These devices are used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging 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, DC, and Puerto Rico) and numerous international locations.

The source text does not specify instructions for consumers or healthcare facilities on how to proceed with the recall or remediation.

The recalled product

Product
Ingenuity Core 128 (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
288

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 #: 728323
  • Serial #s: 30153
  • 32002
  • 32003
  • 32004
  • 32005
  • 32006
  • 32007
  • 32009
  • 32010
  • 32011
  • 32013
  • 32014
  • 32015
  • 32016
  • 32018
  • 32021
  • 32023
  • 32025
  • 32026

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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