LANTIS Oncology Information System (OIS) Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens. An oncol
FDA device recall Z-2983-2011 · posted 2011-08-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LMB
- Quantity affected
- 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, Irela
- Date initiated
- 2011-06-30
- Date posted
- 2011-08-10
- Date terminated
- 2012-03-09
- Location
- Concord, CA
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