Food, drugs, devices › Medtronic Navigation, Inc.-Littleton
Device recall: Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage):
Medtronic Navigation, Inc.-Littleton (Littleton, MA) initiated this device recall on 1 May 2019; FDA lists 1 product record under event 82991, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 19 Jan 2021. Initiation: voluntary: firm initiated. Medtronic Navigation, Inc.-Littleton has 11 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Navigation, Inc.-Littleton, Littleton, MA.
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…"
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1932-2019 | 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… | 832 units | Class II | Terminated | 10 Jul 2019 |
Context
Other enforcement events for Medtronic Navigation, Inc.-Littleton
All 11 events for Medtronic Navigation, Inc.-Littleton
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide Foreign: ALGERIA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL BULGARIA CANADA CANADA CHILE CHINA COLOMBIA CROATIA CZECH REPUBLIC DENMARK EGYPT FINLAND FRANCE…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Jan 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.