FDAFDA · Food and drugs·Recall number Z-0785-2014
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
Published January 29, 2014 · Recall initiated: December 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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