The Recall Desk
HighFDA (Devices)·Z-1021-2016·Announced 2016-03-09

Philips Recalls BrightView X Gamma Cameras Due to Motion and Collision Issues

Philips Medical Systems is recalling 117 BrightView X gamma cameras worldwide due to potential gantry motion halts and collimator contact with the patient pallet.

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 source describes a risk-of-harm product (medical imaging equipment) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 117 units of the BrightView X gamma cameras, which are designed for single or dual detector nuclear imaging. The recall covers units distributed worldwide, including the United States, Puerto Rico, and numerous international countries.

The firm identified four issues with the systems, two of which are detailed in the notice. First, during a cardiac non-Auto Body Contouring (ABC) scan using Cardiac High Resolution (CHR) collimators, the collimator may come into contact with the bottom edge of the patient pallet; if this occurs, collision sensors are designed to pause the scan. Second, during a scan, the gantry motion may halt prematurely. The source text does not specify the nature of the remaining two issues.

Affected units are identified by Model # 882478 and specific serial numbers ranging from 11000003 to 11000118, as well as 11340001 to 11340005 and 11000015. The source text does not provide specific instructions for consumers or healthcare providers on how to proceed with the recall or remediation.

The recalled product

Product
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
117

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 #: 882478
  • Serial #'s: 11000003
  • 11000008
  • 11000030
  • 11000004
  • 11000005
  • 11000006
  • 11000007
  • 11000009
  • 11000010
  • 11000011
  • 11000012
  • 11000013
  • 11000014
  • 11000016
  • 11000017
  • 11000018
  • 11000019
  • 11000020
  • 11000022

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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