The Recall Desk
HighFDA (Devices)·Z-1771-2015·Announced 2015-06-17

Philips Medical Systems Recalls Ingenuity Core UPS Accessory Devices

Philips Medical Systems is recalling 215 Ingenuity Core 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) with potential for chemical exposure (battery acid) and fire (overheating/fumes), but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 215 units of Ingenuity Core 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.

Healthcare facilities and consumers should identify affected units by checking the model number (728321) and serial numbers listed in the official recall notice. The source text does not specify specific consumer actions beyond the identification of the affected devices.

The recalled product

Product
Ingenuity Core (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 Equipment
Hazard
Affected units
215

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 #: 728321
  • Serial #s: 52000
  • 52001
  • 52002
  • 52004
  • 52006
  • 52007
  • 52008
  • 52009
  • 52010
  • 52013
  • 52015
  • 52016
  • 52017
  • 52018
  • 52020
  • 52021
  • 52022
  • 52024
  • 52026

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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