Recall Z-0168-2015— Iba Dosimetry Gmbh
Class II · Terminated
Class II FDA medical device recall by Iba Dosimetry Gmbh, initiated 2014-09-25, terminated 2015-01-26. It names one FDA 510(k) clearance: K072374. Product: COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological. Reason: 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..
- Recalling firm
- Iba Dosimetry Gmbh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-25
- Terminated
- 2015-01-26
- Firm location
- Schwarzenbruck, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.