CLASS II Device recall · Reported 18 Dec 2013 · FDA Enforcement Report

iba Compass SW recalled by Iba Dosimetry

Iba Dosimetry is recalling iba Compass SW, distributed nationwide in the US. The recall was initiated on 20 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSW Version 3.0. Catalong Number CS10-100

Quantity recalled33 units

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-0456-2014
FDA event ID: 66808
Recalling firm: Iba Dosimetry, Schwarzenbruck
Classification: Class II
Status: Terminated
Recall initiated: 20 Aug 2013
FDA classified: 6 Dec 2013
Reported: 18 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Aug 2013	Recall initiated by company
6 Dec 2013	Classified by FDA	+108 days
18 Dec 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.

Product as listed by the FDA

iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

Where it was distributed

Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.

Nationwide California Connecticut Massachusetts New York Ohio Oklahoma South Carolina

Questions about this recall

Is iba Compass SW recalled?

Yes. Iba Dosimetry recalled iba Compass SW on 20 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-0456-2014.

Why was it recalled?

Which lots are affected?

SW Version 3.0. Catalong Number CS10-100

Where was it sold?

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.

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27 Jan 2016Device	CLASS II	GmbH Lift Table Type recalled by Iba Dosimetry	Iba Dosimetry	Other	Nationwide
4 Mar 2015Device	CLASS II	Compass SW recalled by Iba Dosimetry	Iba Dosimetry	Device Malfunction	AZ, OK
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