ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma recall
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
Why was ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 255 units
- Distribution
- 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.
- Recall date
- January 29, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)