ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. Manufactured by Siemens AG, Medical Solutions, Kemnath, German
FDA device recall Z-2977-2011 · posted 2011-08-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- A potential safety rick related to transferring reference images for offset calculation between a syngo RT Therapist v 4.2 or a syngo RT Oncologist 4.2 and other versions of the COHERENCE/syn go RT Therapist or Oncologist or vice versa. An incorrect offset may be applied for patient positioning and result in dose being delivered to the wrong location.
- Action taken
- Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION/CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides preventive measure instructions for customers to use until an update for the system is available.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 121 devices
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of CA, FL, NC, NY, OH, PA, SD, UT, and WI and countries of Australia, Belgium, Croatia, Czech Republic, Germany, India, Ireland, Japan, Pol
- Date initiated
- 2011-06-03
- Date posted
- 2011-08-10
- Date terminated
- 2012-03-30
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CDB CLIP (K080906) | Cdb Corporation | 2008-10-17 |