Reported Nov 12, 2014 · Terminated
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Iba Dosimetry GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Iba Dosimetry Gmbh · Bahnhofstr. 5 · Schwarzenbruck, N/A · N/A
Is this the product you have?
- COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
- Lot codes and dates
- N/A
- Amount recalled
- 124 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Iba Dosimetry GmbH recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.