# FDA recall Z-1932-2019

> **Medtronic Navigation, Inc.-Littleton** · Class II · device recall initiated 2019-05-01.

## Product

Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage):  Product Name Model#/ CFN  OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027  OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R  BASE OARM 8170000027100 SYSTEM !DOV BI70000027100  BASE OARM Bl70000027100R SYSTEM lOOV RWK Bl70000027100R  BASE OARM 8170000027120 SYSTEM 120V 8170000027120  BASE OARM Bl70000027120R SYSTEM 120V RWK BI70000027120R  BASE OARM Bl70000027230 SYSTEM 230V 8170000027230  BASE OARM Bl70000027230R SYSTEM 230V RWK BI70000027230R  OARM ASSY BI70000027GER SYS PRODUCT GER BI70000027GER  OARM ASSY Bl70000027GERR SYS PRODUCT REFURB BI70000027GERR  BASE OARM 8170000028100 SYS lOOV 8170000028100  BASE OARM BI70000028120 SYS 120V 8170000028120  BASE OARM BI70000028120R 3RD EDIT REFURB BI70000028120R  BASE OARM BI70000028230 SYS 230V BI70000028230  BASE OARM BI70000028230R 3RD EDIT REFURB Bl70000028230R    Product Usage:  The 0-arrn Imaging System is a mobile 

## Reason for recall

The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced

## Distribution

Worldwide Distribution - US Nationwide  Foreign:  ALGERIA  AUSTRALIA  AUSTRIA  BAHRAIN  BELGIUM  BRAZIL  BULGARIA  CANADA  CANADA  CHILE  CHINA  COLOMBIA  CROATIA  CZECH REPUBLIC  DENMARK  EGYPT  FINLAND  FRANCE  GERMANY  GREECE  HONG KONG  INDIA  IRELAND  ISRAEL  ITALY  JAPAN  JORDAN  KAZAKHSTAN  KOREA  KOREA, REPUBLIC OF  KUWAIT  LEBANON  LIBYAN ARAB JAMAHIRIYA  LK  MEXICO  NETHERLANDS  NEW ZEALAND  NICARAGUA  POLAND  PORTUGAL  PUERTO RICO  RUSSIAN FEDERATION  SAUDI ARABIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  TURKEY  UNITED ARAB EMIRATES  UNITED KINGDOM  VENEZUELA

## Key facts

- **Recall number:** Z-1932-2019
- **Recalling firm:** Medtronic Navigation, Inc.-Littleton
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-01
- **Report date:** 2019-07-10
- **Termination date:** 2021-01-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Littleton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1932-2019

## Citation

> AI Analytics. FDA recall Z-1932-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1932-2019. Source: US FDA. Licensed CC0.

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