RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen 25, SE-111
FDA device recall Z-1317-2012 · posted 2012-03-26 · Terminated
Recall details
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Reason for recall
- An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient.
- Action taken
- The firm decided to recall and sent Urgent Field Safety Notice Medical Device Correction letters to consignees on 12/06/2011. The letters described the issue, identified the affected product, actions to be taken by the user, a solution, and contact information. Users are to follow the two part workaround, and educate their staff and all users on the workarounds. The letter states that the issue will be resolved in the next version of RayStation. If further information is needed, users are to contact either Freddie Cardel, Director of Customer Support, RaySearch Americas, at 1-877-778-3849 or freddie.cardel@raysearchlabs.com; or Niclas Borglund, Director of Service, RaySearch Laboratories AB, at 46-8-5450-6130 or niclas.borglund@raysearchlabs.com
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 21 units (16 domestically and 5 internationally)
- Distribution
- Worldwide Distribution -- US, including the states of FL, MA, NJ, and NY and the country of the Netherlands.
- Date initiated
- 2011-12-06
- Date posted
- 2012-03-26
- Date terminated
- 2012-05-11
- Location
- Stockholm, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RAYSTATION VERSION 1.0 (K100552) | Raysearch Laboratories AB | 2010-03-12 |