CLASS II Device recall · Reported 12 Nov 2014 · FDA Enforcement Report
Compass, Model No. SW Version recalled by Iba Dosimetry
Iba Dosimetry is recalling Compass, Model No. SW Version 3.1, catalogue number CS10-100 (medical. The recall was initiated on 25 Sep 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0168-2015
- FDA event ID
- 69583
- Recalling firm
- Iba Dosimetry, Schwarzenbruck, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Sep 2014
- FDA classified
- 4 Nov 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Processing Deviation
- Device type
- Other Medical Devices
Timeline
| 25 Sep 2014 | Recall initiated by company | |
| 4 Nov 2014 | Classified by FDA | +40 days |
| 12 Nov 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Where it was distributed
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, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.
Questions about this recall
Is Compass, Model No. SW Version 3.1, catalogue number CS10-100 (medical recalled?
Yes. Iba Dosimetry recalled Compass, Model No. SW Version 3.1, catalogue number CS10-100 (medical on 25 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0168-2015.
Why was it 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.
Which lots are affected?
N/A
Where was it sold?
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, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Iba Dosimetry
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