COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
FDA device recall Z-0168-2015 · posted 2014-11-04 · Terminated
Recall details
- Recalling firm
- Iba Dosimetry Gmbh
- Reason for recall
- Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.
- Action taken
- The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on 09/25/2014.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 124 units
- Distribution
- Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexic
- Date initiated
- 2014-09-25
- Date posted
- 2014-11-04
- Date terminated
- 2015-01-26
- Location
- Schwarzenbruck, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPASS (K072374) | Scanditronix Wellhofer GmbH | 2007-12-07 |