Medtronic Navigation, Inc.-Littleton

Complete recall history across all FDA and CPSC categories — 20 total recalls

Medtronic Navigation, Inc.-Littleton appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (20)

FDA medical device enforcement actions by Medtronic Navigation, Inc.-Littleton

Date Product Reason Class
Apr 26, 2024 O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and ... Potential for an electrical component of the O-arm" O2 Imaging System to inte... Class II
Jul 25, 2023 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluorosc... Ground cable installed incorrectly. Class II
Nov 15, 2019 O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, ... Class II
May 1, 2019 Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XX... The 0-arm 1000 Imaging System uses energy from the batteries to generate X-ra... Class II
Sep 17, 2018 Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ra... O-arm 02 Imaging Systems correction to software version 4.1.0; new version of... Class II
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GE... Software anomalies were reported to affect the following system functionaliti... Class II
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, M... Software anomalies were reported to affect the following system functionaliti... Class II
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100 SYSTEM lOOV, M... Software anomalies were reported to affect the following system functionaliti... Class II
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV R... Software anomalies were reported to affect the following system functionaliti... Class II
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, M... Software anomalies were reported to affect the following system functionaliti... Class II
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 1... Software anomalies were reported to affect the following system functionaliti... Class II
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230R SYSTEM 230V R... Software anomalies were reported to affect the following system functionaliti... Class II
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GERR SYS PRODUCT R... Software anomalies were reported to affect the following system functionaliti... Class II
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK,... Software anomalies were reported to affect the following system functionaliti... Class II
Aug 30, 2018 O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, M... Software anomalies were reported to affect the following system functionaliti... Class II
Jan 25, 2018 O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BAS... Software update ("SW Update 3.2.1") is being implemented to address the follo... Class II
Sep 30, 2017 O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02... During servicing of certain internal components of the O-Arm O2 Surgical Imag... Class II
Sep 22, 2016 Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number:... O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stea... Class II
Mar 17, 2016 Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027,... It has been discovered that replacement x-ray generator and system motion bat... Class II
Mar 17, 2016 Medtronic Navigation O-arm 02 surgical x-ray imaging system Review of on-system electronic product labeling and Instr uctions for Use in ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.