| | Class 2 Device Recall ECAT ART |  |
| Date Initiated by Firm | July 23, 2007 |
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| Date Posted | November 29, 2007 |
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| Recall Status1 |
Terminated 3 on September 11, 2009 |
| Recall Number | Z-0270-2008 |
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| Recall Event ID |
45154 |
| 510(K)Number | K002584 K003541 K940478 K962797 |
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| Product Classification |
Tomography Computed Emission System - Product Code KPS
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| Product | Siemens ECAT ART, Catalog No.. 3545584, 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: 3600066-00-0001001, 3600066-00-0001002, 3600066-00-0001005, 3600066-00-0001007, 3600066-00-0001008, 3600066-00-0001010, 3600066-00-0001013, 3600066-00-0001014, 3600078-00-0001003, 3600082-00-0001002, 3600084-00_0001005, 3600084-00-0001005, 3600090-00-0001001, 3600090-00-0001002, 3600090-00-0001003, 3600090-00-0201005, 3600090-00-0201006, 3600099-00-001001, 3600099-00-001006, 3600099-00-001009, 3600099-00-0201002, 3600099-00-0201003, 3600099-00-0201004, 3600099-00-0201005, 3600099-00-0201007, 3600099-00-0201008, 3600099-00-0201010, 3600099-00-0201012, 3600099-00-0301013, 3600099-00-0301014, 3600099-00-0301016, 3600099-00-0301017, 3600099-00-0301018, 3600099-00-0301019, 3600099-00-0301020, 3600099-00-0301021, 3600099-00-0301022, 3600099-00-0301023, 3600099-00-0301024, 3600099-00-0301025, 3600099-00-0301026, 3600099-00-0301027, 3600099-00-0301028 |
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA Inc
810 Innovation Dr
Knoxville TN 37932-2562
|
| For Additional Information Contact | Maria Ebio
865-218-2534 |
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Manufacturer 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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FDA Determined
Cause 2 | Software design |
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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 | 43 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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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = KPS
510(K)s with Product Code = KPS
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