CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report

Medtronic 0-arm 02 Imaging System recalled by Medtronic Navigation

Medtronic Navigation is recalling Medtronic 0-arm 02 Imaging System. The recall was initiated on 29 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: C0936

Quantity recalled1 unit

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-1088-2016
FDA event ID: 73303
Recalling firm: Medtronic Navigation, Littleton, MA
Classification: Class II
Status: Terminated
Recall initiated: 29 Jan 2016
FDA classified: 8 Mar 2016
Reported: 16 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

29 Jan 2016	Recall initiated by company
8 Mar 2016	Classified by FDA	+39 days
16 Mar 2016	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

Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System is compatible with certain image guided surgery systems.

Where it was distributed

Worldwide Distribution to Austria only.

Questions about this recall

Is Medtronic 0-arm 02 Imaging System recalled?

Yes. Medtronic Navigation recalled Medtronic 0-arm 02 Imaging System on 29 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-1088-2016.

Why was it recalled?

Which lots are affected?

Serial Number: C0936

Where was it sold?

Worldwide Distribution to Austria only.

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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