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Terminated

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

FDA Recall Z-2082-2016 · Posted None

Recalling FirmMedtronic Navigation, Inc.-Littleton
Recall StatusTerminated
Product CodeOXO
Date Initiated2016-03-17
Date Terminated2021-04-06
Product QuantityUS - 581

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.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092564O-ARM IMAGING SYSTEMMedtronic Navigation, Inc. (Littleton) · 2010-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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