The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0881-2013·Announced 2013-03-06

Philips Medical Systems Recalls Extended Brilliance Workspace X-Ray Scanners

Philips Medical Systems is recalling 39 Extended Brilliance Workspace X-Ray Scanners because a software anomaly may cause generated data sets to be flipped and incorrectly labeled.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 39 units of the Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. These devices are components of the Computed Tomography X-Ray System. The recall covers units distributed worldwide, including the United States and Canada.

The recall is due to a software anomaly in the TumorLOC program. The firm identified that Intensity Projection data sets generated from respiratory gated data can be 'flipped' and incorrectly labeled left-to-right when saved to disk. This error may affect the accuracy of the data sets.

Affected units are identified by specific serial numbers listed in the recall notice. Users should contact Philips Medical Systems for further instructions regarding the software update.

The recalled product

Product
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — X-Ray Scanner
Hazard
Affected units
39

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)

  • The EBW Serial Numbers subject to software updates are as follows: 8222
  • 8235
  • 8270
  • 8838
  • 8841
  • 8862
  • 9014
  • 9019
  • 9127
  • 10331
  • 10348
  • 10402
  • 10705
  • 10749
  • 10827
  • 11002
  • 11362
  • 11365
  • 11588
  • 11597

Distribution

Distributed in 43 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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