CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report
O-arm 1000 2nd Edition Imaging System recalled by Medtronic Navigation
Medtronic Navigation Inc.-Littleton is recalling O-arm 1000 2nd Edition Imaging System, Oarm Assy Bl70000027R Sys Product Rwk, distributed in 45 states. The recall was initiated on 30 Aug 2018 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-0272-2019
- FDA event ID
- 81153
- Recalling firm
- Medtronic Navigation Inc.-Littleton, Littleton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Aug 2018
- FDA classified
- 25 Oct 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 30 Aug 2018 | Recall initiated by company | |
| 25 Oct 2018 | Classified by FDA | +56 days |
| 31 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm 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 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Where it was distributed
Worldwide - US Distribution in the states: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and Puerto Rico. The products were distributed to the following foreign countries: Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Venezuela.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
Which lots are affected?
All Serial Numbers
Where was it sold?
Worldwide - US Distribution in the states: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and Puerto Rico. The products were distributed to the following foreign countries: Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK, Venezuela.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 81153This product is part of a recall event; the main page for the event is O-arm 1000 2nd Edition Imaging System recalled by Medtronic Navigation.
More recalls from Medtronic Navigation Inc.-Littleton
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|---|---|---|---|---|---|
| Device | CLASS II | O-arm O2 Imaging System-Mobile x-ray system designed recalled | Medtronic Navigation Inc.-Littleton | Device Malfunction | Nationwide |
| Device | CLASS II | The O-arm O2 Imaging System is a mobile x-ray system recalled | Medtronic Navigation Inc.-Littleton | Other | Nationwide |
| Device | CLASS II | O-arm" O2 Imaging System, Product Number/CFN: BI recalled | Medtronic Navigation Inc.-Littleton | Other | 23 states |
| Device | CLASS II | Medtronic 0-arm TM 1000 Imaging Systems recalled by Medtronic Navigation | Medtronic Navigation Inc.-Littleton | Other | Nationwide |
| Device | CLASS II | Medtronic Navigation 0-arm 02 Imaging System interventional recalled | Medtronic Navigation Inc.-Littleton | Device Malfunction | Nationwide |
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