The Recall Desk
HighFDA (Devices)·Z-1751-2017·Announced 2017-04-12

Philips BrightView XCT Gamma Cameras Recalled for Brake Hub Assembly Error

Philips is recalling 90 BrightView XCT gamma cameras because a brake hub assembly error can cause the detector to backdrive.

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 is classified as FDA Class II, and the hazard involves a mechanical failure (detector backdrive) that poses a risk of harm to patients or equipment, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 90 units of the BrightView XCT model number 882482. These are gamma cameras designed for single or dual detector nuclear imaging, including SPECT studies. The devices are used by trained healthcare professionals to perform planar static, dynamic, gated, and total body studies.

The recall is due to an error in the assembly of components within the brake hub mechanism after service. This error prevented the brake hub from engaging with the gear box shaft, which caused the detector to backdrive. The affected systems were distributed worldwide, including in the United States, Canada, Mexico, and numerous other international locations.

Healthcare facilities and users should stop using the affected BrightView XCT systems and contact Philips Medical Systems for instructions on how to resolve the issue. The recall includes specific government and international accounts, and users should verify their equipment against the provided serial numbers to determine if their unit is affected.

The recalled product

Product
BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
90

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)

  • 6000203
  • 6000396
  • 6000229
  • 6000195
  • 6000204
  • 6000402
  • 6000237
  • 6000093
  • 6000206
  • 6000022
  • 6000416
  • 6000330
  • 6000130
  • 6000339
  • 6000276
  • 6000086
  • 6000051
  • 6000351
  • 6000188
  • 6000065

Distribution

Distributed in 29 states:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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