Skip to content
Recall Observatory FDA recall evidence

Device product

ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH

Z-0785-2014

December 04, 2013

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 67130
Status
Terminated
Classification
Class II
Quantity
255 units
Official record key
device-enforcement:Z-0785-2014

Official wording

Reason: The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.

Code information: ADAC ARGUS: Model #882060; Serial #: 1023, 1178, 106785, 136560, 1100005, 9051005, 9304030, 9309011, 9501007, 9509005, 9510027, 9510028, 9603042, 9603043, 9604044, 9604047, 9605011, 9607060, 9609065, 9610072, 9704081, 9709090, 9710097, 9711103, 9712105, 9712106, 9801107, 9801109, 9802112, 9803001, 9803116, 9804126, 9804129, 9806136, 9807138, 9807422,9810527, 9901156, 9901160, 9901162, 9908167, 9909172, 9910176, 00709B, 0101003A, 01310B, 01525B, 01920B, 01921B, 01922B, 03041B, 03094B, 03338B, 03368B, 2145-30074A, 7718B, A0103015, A0103213, A0105217, A02100230, A02100231, A02110248, A02110249, A02110250, A02110251, A02120254, A02120256, A03010262, A03010264, A03010265, A03010266, A03010270, A03020274, A03020275, A03030282, A03070283, A03120294, B0003196, B0007200, B0309014, ID3935B, M@10639, M@10645, M@10774, M@10777, M@10877, M@11239, M@11568, M@11640, M@11684, M@11685, M@11729, M@11769, M@11813, M@11947, M@12378-1, M@12462, M@12765, M@13725, M@24470, M@4750028851, M@4750028853, M@5348B, M@5807B, M@5874B, M@5894B, M@5932B, M@5941B, M@5963B, M@6041B, M@6062B, M@6229B, M@6354B, M@6477B, M@6485B, M@6546B, M@6555B, M@6692B, M@6754B, M@6809B, M@6815B, M@6948B, M@7007B, M@7023B, M@7093B, M@7194B, M@7198B, M@7207B, M@7214B, M@7280B, M@7285B, M@7286B, M@7408B, M@7540B, M@7596B, M@7675B, M@7704B, M@8156B, M@8324B, M@8344B, M@8429B, M@8523B, M@8578B, M@8588B, M@8637B, M@8639RB, M@8648B, M@8808B, M@8813B, M@8898B, M@8977B, M@9050B, M@9261B, M@9276B, M@9355RB, M@9475B, M@9544B, M@9647B, M@9656B, M@9733B & M@9796B. ADAC ARGUS: Model #88295; Serial #: 9211014, 9301005, 9304019, 9304024, 9304028, 9401028, 9401031, 9401037, 9505014, 9910033, 93-10678- 1292, 9910028P, M@10225AMT, M@3732B, M@3903B, M@3954B, M@3956B, M@3960B, M@4249B, M@4415B, M@4646B, M@4868B, M@5172B, M@5321B, M@7341B & M@AMT1154. ADAC CIRRUS: Model #88294; 34, 718558, 9206009, 9207003, 9207004, 9207005, 9207007, 9211006, 9300113, 9304013, 9309012, 9404022, 9407028, 9509042, 9604098, 9910030, 93-10735-0393, 9621RQ, M@10110AMT, M@10324AMT, M@10402AMT, M@3599G-08, M@3905Q, M@4029Q, M@4129Q, M@4142Q, M@4668Q, M@4743Q, M@5003Q, M@5668Q, M@5895Q, M@AMT126R, M@AMT1282 & M@MVS3227A.

Distribution pattern: Worldwide Distribution: US (nationwide) including states of: AL, AR, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TN, TX, VA, VT, WA, WI & WV; and Internationally to: Austria, Belgium, Canada, Denmark, Germany, Great Britain, Italy, Netherlands, Norway, Pakistan, Russia, Singapore & South Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.