Z-2082-2016Class II

Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

Name: Z-2082-2016 Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
Creator: Medtronic Navigation, Inc.-Littleton
Published: 2016-03-17
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2016-03-17 / Terminated

FDA source

Medtronic Navigation, Inc.-Littleton began a recall of Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028 on 2016-03-17. FDA classified it as Class II and gives the reason as "It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2082-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-17
Posted: 2016-07-06
Terminated: 2021-04-06
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
Product code: OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Reason for recall: It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.
FDA root cause: Radiation Control for Health and Safety Act
Action: Medtronic's planned action to bring device into Compliance. 1. You will provide an Errata sheet to customers updating the missing and incorrect information. 2. Field Service Engineers (FSEs) will perform radiation output measurements via validated procedures to attain compliance with 21CFR part 1020.32(k)(6). 3. You will inspect and test X-ray generator and system motion batteries for damage, in accordance with the plan submitted to CDRH. Damaged batteries will be replaced. 4. You will update the systems software-based instructions for use by a software update which includes the information supplied by the Errata sheet. For further questions, please call (800) 595-9709.
Quantity in commerce: US - 581
Distribution: Nationwide Distribution
Product codes and lots: Model No. BI-700-00027 and BT-700-00028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2082-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2082-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)