Z-0272-2019Class II

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R

Name: Z-0272-2019 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R
Creator: Medtronic Navigation, Inc.-Littleton
Published: 2018-08-30
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2018-08-30 / Terminated / root cause: software

FDA source

Medtronic Navigation, Inc.-Littleton began a recall of 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... on 2018-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0272-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-30
Posted: 2018-10-25
Terminated: 2020-06-18
Recalling firm: Medtronic Navigation, Inc
Product: 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.
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
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.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction notification letters were sent to customers on 8/30/18. The letter identified the affected letter, problem and actions to be taken. All consignees will received the notification for 3.1.7 software maintenance release. Field service personnel will install the software onto the designed consignee systems.
Quantity in commerce: 596 total
Distribution: 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.
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0272-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0271-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0272-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0273-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0274-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0275-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0276-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0277-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0278-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0279-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25
Z-0280-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-25

Product code OXO

K092564Class IIO-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton) / cleared 2010-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)