The Recall Desk
HighFDA (Devices)·Z-0785-2014·Announced 2014-01-29

Philips Recalls ADAC Gamma Camera Systems Due to Fork Joint Crack Risk

Philips Medical Systems is recalling ADAC ARGUS and CIRRUS Gamma Camera Systems because routine maintenance may fail to detect small cracks in the fork weldments.

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 involves a structural defect in a medical device where injury has not yet been reported, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 255 units of ADAC ARGUS and ADAC CIRRUS Gamma Camera Systems. The recall covers specific model and serial numbers distributed worldwide, including nationwide distribution in the United States and international distribution to several countries.

The recalling firm determined that visual inspections of the fork joints behind the detector, which are conducted during six-month preventive maintenance, may not detect small cracks or deficiencies in the fork weldment. This defect could potentially compromise the structural integrity of the equipment.

Healthcare facilities and users of these systems should contact Philips Medical Systems for instructions on how to address the issue. The source text does not specify a specific action for consumers, but users should follow the manufacturer's guidance for inspection or repair.

The recalled product

Product
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
255

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)

  • ADAC ARGUS: Model #882060
  • Serial #: 1023
  • 1178
  • 106785
  • 136560
  • 1100005
  • 9051005
  • 9304030
  • 9309011
  • 9501007
  • 9509005
  • 9510027
  • 9510028
  • 9603042
  • 9603043
  • 9604044
  • 9604047
  • 9605011
  • 9607060
  • 9609065

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically:

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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Same hazard · structural defect

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