The Recall Desk
ModerateFDA (Devices)·Z-1753-2017·Announced 2017-04-12

Philips BrightView X Gamma Camera Recall Due to Brake Hub Assembly Error

Philips Medical Systems is recalling 27 BrightView X gamma cameras because a brake hub assembly error can cause the detector to backdrive.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The agency classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a mechanical defect (backdriving) without reported injuries or illnesses.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 27 units of the BrightView X 3/8 gamma camera, model number 882478. These devices are used for nuclear imaging and SPECT studies by trained healthcare professionals.

The recall was initiated because the brake hub was not engaging with the gearbox shaft. This issue resulted from an error in the assembly of components within the brake hub mechanism after service. The defect causes the detector to backdrive.

The affected systems were distributed worldwide, including in the United States, Canada, and Mexico. No specific consumer action is detailed in the source text, but the devices should be handled according to the recalling firm's instructions.

The recalled product

Product
BrightView X 3/8 model number 882478 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, an
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
27

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)

  • 11000105
  • 11000116
  • 11000018
  • 11000047
  • 11000046
  • 11000010
  • 11000068
  • 11000098
  • 11000083
  • 11000013
  • 11000107
  • 11000056
  • 11000042
  • 11000093
  • 11000089
  • 11000104
  • 11000077
  • 11000028
  • 11000085
  • 11000040

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 →

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland) Inc

See all →

Same hazard · mechanical defect

See all →