Agency classClass IIOur severity:High FDA (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.

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 3/5 (High).

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: structural-defect
equipment-failure
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:

Same manufacturer · Philips Medical Systems (Cleveland) Inc

See all →

High
Radiation planning software recalled over image errors in three patient orientations
FDA (Devices) · 2025-09-24
High
Pinnacle 3 radiation planning software may miscalculate stopping power ratio
FDA (Devices) · 2025-08-13
High
Pinnacle3 Radiation Therapy Planning System dose-calculation software error
FDA (Devices) · 2022-09-21
Severe
Philips Forte Gamma Camera System Recalled for Detector Fall Hazard
FDA (Devices) · 2019-11-13
Severe
Philips Forte Gamma Camera System Recalled Due to Detector Falling Hazard
FDA (Devices) · 2019-11-13

Same hazard · structural defect