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U.S. Department of Health and Human Services

Class 2 Device Recall IMPAC / Elekta Medicals Sequencer

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 Class 2 Recall
IMPAC / Elekta Medicals Sequencer
see related information
Date Posted August 10, 2011
Recall Status1 Terminated on March 09, 2012
Recall Number Z-2983-2011
Recall Event ID 59347
Product Classification Device, Digital Image Storage, Radiological - Product Code LMB
Product LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens. An oncology digital imaging information management system. Lantis OIS in combination with Sequencer and a non-Siemens linac interface. System components include: LANTIS Commander, LANTIS system, LANTIS 6.1 Commander, LANTIS 8.3 Commander. Subcomponents include: Linac Interface, other vendor, LANTIS Varian Clinac, LANTIS GE Saturn, LANTIS Philips SLS, LANTIS Philips 75 ASU, LANTIS Elekta (Philips) and LANTIS Varian EX I/F.
Code Information LANTIS Commander. Part Number 4503178; LANTIS system, Part Number 5835991; LANTIS 6.1 Commander, Part Number 5493072; LANTIS 8.3 Commander, Part Number 8148178 Linac Interface, other vendors: Part Number 4504994; LANTIS Varian Clinac, Part Number 1929251; LANTIS GE Saturn, Part Number: 1929277; LANTIS Philips SLS, Part Number 4507203; LANTIS Philips 75 ASU, Part Number 5494120; LANTIC Elekta (Philips), Part Number 5502880; LANTIS Varian EX I/F, Part Number 5846220.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord, California 94520-1200
For Additional Information Contact Christine Dunbar
925-602-8157
Manufacturer Reason
for Recall
A potential safety issue exists for data transfer between LANTIS OIS system (containing PRIMEVIEW or PRIMEVIEW Data Gateway) and the Sequencer V&R system via a third party interface is used.
FDA Determined
Cause 2
DESIGN: Software Design
Action Siemens sent an "Update Instructions/Customer Safety Advisory Notice" to all affected users, beginning June 30, 2011. The letter includes description of the product and problem and provides updated instructions to ensure data is stored in the system. If you have questions contact Siemens at (925) 602-8157.
Quantity in Commerce 59 devices
Distribution Worldwide Distribution: Nationwide (USA) including the states of MI, DE, WI, FL, CA, TN, NJ, PA, NE, IL, WV , MA and VA; and the countries of Poland, France, Germany, Canada, Netherlands, India, Ireland, Egypt, P.R. china, Australia, Saudi Arabia, Turkey, Republic Korea, Belgium, Hungary, New Zealand, Italy, Malaysia, and Spain.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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