MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a a
FDA device recall Z-1270-2012 · posted 2012-03-21 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, for RT Therapist version 2.1A
- Action taken
- Siemens sent a Customer Information letters to all affected customers. The Customer information letters inform customers of the release of MOSAIQ 2.00X3 SP5 which specifically addresses a safety issue that is only found when MOSAIQ is used with COHERENCE Therapist 2.1 MQ (also called RTT2.1A). This letter is to be kept with Customer information documentation. Update Instruction TH004/12S are being issued with the update. The Software update is delivered and installed by qualified Field Service Engineers. For questions, contact your responsible SIEMENS Service Engineer or Application Specialist.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 44 affected Siemens Customers
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of KY, PA, TN, WI, and P.R. and the countries of Australia, Belgium, Bosnia Herzeg. China, Colombia, Croatia, Czech Republic, Germany, In
- Date initiated
- 2012-02-14
- Date posted
- 2012-03-21
- Date terminated
- 2012-09-21
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO RT THERAPIST CONNECT (K090683) | Siemens Medical Solutions USA, Inc. | 2009-05-08 |
| SEQUENCER (K981313) | Impac Medical Systems, Inc. | 1998-07-09 |