The Recall Desk
HighFDA (Devices)·Z-1769-2015·Announced 2015-06-17

Philips iCT SP UPS Accessory Devices Recalled for Battery Acid Leakage Risk

Philips Medical Systems is recalling 110 iCT SP 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

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 (battery acid leakage, overheating, fumes) from a medical device where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 110 units of iCT SP 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 after the firm was notified that the UPS accessory devices may fail, resulting in battery acid leakage, overheating, and/or emission of fumes.

The affected devices are identified by Model # 728311 and specific serial numbers ranging from 200021 to 200138, with certain gaps in the sequence. The products were distributed worldwide, including the United States (nationwide, DC, and Puerto Rico) and numerous international locations.

Consumers and healthcare facilities should check their inventory for these specific model and serial numbers. If the devices are found, they should be removed from service and the recalling firm contacted for further instructions.

The recalled product

Product
iCT SP (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
110

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 #: 728311
  • Serial #s: 200021
  • 200022
  • 200023
  • 200024
  • 200025
  • 200026
  • 200027
  • 200029
  • 200030
  • 200031
  • 200032
  • 200033
  • 200034
  • 200035
  • 200036
  • 200037
  • 200038
  • 200039
  • 200040

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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