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Class 2 Device Recall SOMATOM Sensation Cardiac ( Straton) |
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Date Initiated by Firm |
September 28, 2004 |
Date Posted |
November 03, 2004 |
Recall Status1 |
Terminated 3 on September 04, 2008 |
Recall Number |
Z-0161-05 |
Recall Event ID |
30173 |
Product Classification |
System, X-Ray, Tomography, Computed - Product Code JAK
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Product |
SOMATOM CT System Sensation Cardiac (+ Straton), Computed Tomography X-Ray System, Model Numbers 75 43 106 |
Code Information |
Serial Numbers: 52948, 52950, 52951, 52952, 52953, 52954, 52955, 52956, 52957, 52958, 52959, 52960, 52961, 52962, 52963, 52964, 52965, 52966, 52967, 52968, 52969, 52971, 52972, 52973, 52974, 52975, 52976, 52977, 52978, 52979, 52980, 52981, 52982, 52983, 52984, 52985, 52986, 52988, 52989, 58990, 52991, 52992, 52993, 52994, 52996, 52997, and 58999 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
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For Additional Information Contact |
Roland Richter, 610-448-1777
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Manufacturer Reason for Recall |
Calcium Scoring feature on this devices is not closing properly after patient's exams.
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FDA Determined Cause 2 |
Other |
Action |
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue. |
Quantity in Commerce |
47 units |
Distribution |
The product was shipped to medical facilities nationwide and government account in IL. |
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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