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U.S. Department of Health and Human Services

Class 2 Device Recall ADAC ARGU

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  Class 2 Device Recall ADAC ARGU see related information
Date Initiated by Firm December 04, 2013
Date Posted January 17, 2014
Recall Status1 Terminated 3 on November 06, 2015
Recall Number Z-0785-2014
Recall Event ID 67130
510(K)Number K913471  
Product Classification Camara, x-ray, fluorographic, cine or spot - Product Code IZJ
Product ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH
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.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mrs. Kumudini J. Carter
440-483-3032
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On October 30, 2013 & December 4, 2013, the firm sent Urgent Medical Device Recall letters to their customers.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZJ and Original Applicant = ADAC LABORATORIES
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