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Medical Device Recalls
Class 2 Recall
ECAT ACCEL
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Date Recall
Initiated |
July 23, 2007
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| Date Posted |
November 29, 2007
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| Recall Number |
Z-0269-2008
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| Product |
Siemens ECAT ACCEL, Catalog No. 3554479, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
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| Code Information |
Serial Numbers: 101014, 1303, 1305, 1309, 1310, 1311, 1314, 301089, 301092, 301111, 3600211-00-001003, 3600211-00-001041, 3600211-00-001110, 3600211-00-001122, 3600211-00-0101001, 3600211-00-0101004, 3600211-00-0101005, 3600211-00-0101006, 3600211-00-0101008, 3600211-00-0101012, 3600211-00-0101015, 3600211-00-0101016, 3600211-00-0101017, 3600211-00-0201007, 3600211-00-0201022, 3600211-00-0201023, 3600211-00-0201024, 3600211-00-0201025, 3600211-00-0201026, 3600211-00-0201027, 3600211-00-0201029, 3600211-00-0201031, 3600211-00-0201032, 3600211-00-0201033, 3600211-00-0201035, 3600211-00-0201036, 3600211-00-0201037, 3600211-00-0201038, 3600211-00-0201039, 3600211-00-0201040, 3600211-00-0201041, 3600211-00-0201042, 3600211-00-0201043, 3600211-00-0201045, 3600211-00-0201049, 3600211-00-0201050, 3600211-00-0201051, 3600211-00-0201052, 3600211-00-0201053, 3600211-00-0201054, 3600211-00-0201055, 3600211-00-0201056, 3600211-00-0201057, 3600211-00-0201058, 3600211-00-0201060, 3600211-00-0201061, 3600211-00-0201062, 3600211-00-0201063, 3600211-00-0201064, 3600211-00-0201065, 3600211-00-0201066, 3600211-00-0201067, 3600211-00-0201069, 3600211-00-0201070, 3600211-00-0201071, 3600211-00-0201072, 3600211-00-0201079, 3600211-00-0201080, 3600211-00-0201084, 3600211-00-0201090, 3600211-00-0201091, 3600211-00-0201093, 3600211-00-0201095, 3600211-00-0201103, 3600211-00-0201104, 3600211-00-0201106, 3600211-00-0201115, 3600211-00-0201120, 3600211-00-0301073, 3600211-00-0301075, 3600211-00-0301076, 3600211-00-0301077, 3600211-00-0301078, 3600211-00-0301083, 3600211-00-0301085, 3600211-00-0301086, 3600211-00-0301087, 3600211-00-0301094, 3600211-00-0301096, 3600211-00-0301098, 3600211-00-0301099, 3600211-00-0301100, 3600211-00-0301102, 3600211-00-0301107, 3600211-00-0301108, 3600211-00-0301109, 3600211-00-0401112, 3600211-00-0401113, 3600211-00-0401114, 3600211-00-0401116, 3600211-00-0401117, 3600211-00-201034, 3600211-00-201046, 3600211-00-301097, 3600211-00-301105, 401118
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Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA Inc
810 Innovation Dr
Knoxville
, Tennessee
37932-2562
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| For Addition Information Contact |
Maria Ebio
865-218-2534
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Reason For
Recall |
Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.
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| Action |
Siemans sent an Urgent Device Correction letter, dated June 15, 2007, to all affected consignees informing the user of the problem and requesting that they discontinue the practice of running all transmissions followed by all emissions until a corrective software patch is installed. The corrective software patch is expected to be installed by October 2007.
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| Quantity in Commerce |
105 units
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| Distribution |
Worldwide Distribution - USA and Countries of Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Japan, South Korea, Netherlands, Norway, Saudi Arabia, Sweden, Slovak Republic, Turkey, and Taiwan.
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