The Recall Desk
ModerateFDA (Devices)·Z-0206-2013·Announced 2012-11-14

Philips Recalls Pinnacle3 Virtual Client Connection Software Due to Improper Release

Philips Medical Systems is recalling 11 units of Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and distribution.

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

Plain-English summary

Philips Medical Systems (Cleveland), Inc. is recalling 11 units of Pinnacle3 Virtual Client Connection software version 3.1. The recall was initiated due to an improper release and subsequent distribution of the software.

The Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. The system assists clinicians in formulating treatment plans that maximize the dose to the treatment volume while minimizing the dose to surrounding normal tissues.

The affected software units are identified by serial numbers 317, 318, 319, 320, 321, 342, 343, 344, 345, 346, and 347. The products were distributed nationwide in the United States, including the states of Maine, Michigan, New York, and Wisconsin. The source text does not specify further actions for consumers or report any associated injuries or illnesses.

The recalled product

Product
Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or mali
Manufacturer
Philips Medical Systems (Cleveland), Inc.
Category
Medical Device — Software
Hazard
Affected units
11

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 (11)

  • Serial # 317
  • 318
  • 319
  • 320
  • 321
  • 342
  • 343
  • 344
  • 345
  • 346
  • 347

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland), Inc.

See all →