The Recall Desk
HighFDA (Devices)·Z-1778-2015·Announced 2015-06-17

Philips Precedence 16 UPS Accessory Devices Recalled for Battery Acid Leakage

Philips Medical Systems is recalling 36 Precedence 16 UPS accessory devices used in 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 product (battery acid leakage, overheating, fumes) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 36 units of Precedence 16 Uninterruptible Power Supply (UPS) accessory devices. These devices are used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. The recall affects units with Model # 882350 and specific serial numbers ranging from 300072 to 3000106.

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

Healthcare facilities and consumers should stop using the affected devices immediately. Affected parties should contact Philips Medical Systems for instructions on how to return or replace the units.

The recalled product

Product
Precedence 16 (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
36

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 #: 882350
  • Serial #s: 300072
  • 3000068
  • 3000071
  • 3000073
  • 3000074
  • 3000075
  • 3000076
  • 3000077
  • 3000078
  • 3000079
  • 3000081
  • 3000082
  • 3000083
  • 3000084
  • 3000085
  • 3000086
  • 3000087
  • 3000088
  • 3000089

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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