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Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the…

Medical device recall Z-1932-2019. Published in FDA’s Enforcement Report on Jul 10, 2019.

FDA’s own record

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Jul 10, 2019. Copied from openFDA on Oct 20, 2026.

Class II FDA’s class
Terminated its status, in FDA’s file
Nationwide FDA’s word for where it went
832 units how much, in FDA’s words

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class II, the middle of FDA’s three classes.

“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”

openFDA, in plain words, its enforcement report fields.

“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.”

FDA’s rule, 21 CFR 7.3(m)(2), eCFR.

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

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

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

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 x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomi~ structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

832 units, in FDA’s words.

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Serial Numbers: US: 00102 00103R 00105 00112R 00113 00116R 00117R 00118R 00126 00128R 00129 00131 00133 00134 00135 00138 00140 00147 00148 00149 00152 00157 00158 00164R 00167 00168 00170 00171 00173 00176 00178 00179 00182 00184R 00185…

Every code shown here, 1,991 characters

Serial Numbers: US: 00102 00103R 00105 00112R 00113 00116R 00117R 00118R 00126 00128R 00129 00131 00133 00134 00135 00138 00140 00147 00148 00149 00152 00157 00158 00164R 00167 00168 00170 00171 00173 00176 00178 00179 00182 00184R 00185 00186 00188 00189 00190 00191 00199 00202 00205 00210R 00211 00212 00214 00215 00218 00219 00221 00222 00224 00225 00226 00229 00232R 00234R 00235 00236 00238R 00239 00242 00248 00256 00257 00261 00262 00267 00269 00270 00273 00274R 00275 00277 00280 00282 00288 00289R 00293 00294 00296 00297 00300 00305 00306R 00307 00308 00309R 00311 00312R 00313 00314 00315 00317 O-Arm 318 00319R 00333 00335 00341 00342 00343 00344 00347 00348 00350 00351 00359 00360 00362 00363 00365 00366 00369 00370 00373 00377 00378 00379 00381 00383 00385 00391 00392 00394 00396 00398 00399 00400 00401 00404 00405 00406 00408 00409 00410 00412 00415 00416 00418R O-Arm 420 00428 00429 00432 00433 00435 00438R 00439 00441 00442 00443 00444 00445 00446R 00447 00449 00450 00452 00453 O-arm 457 00458 00461 00462 00465 00466R 00469 00470 00471 00474 00475 00476 00479 00480 00484 00485 00487 00489 00490 00494 00496 00497 00499 00500 00502 00503 00507 O-arm 510 00511 00512 00513 00523 00524 00525 00526 00530 00531 00532 00534 00535 00538 00539R 00540 00541 00542 00543 00544 00546 00547 00550 00551 00553 00554 00555 00556 00561 00562 00564 00566 00567 00568 00569 00570 00572 00573 00574 00576 00579 00581 00582R 00583 00584 00586 00587 00588 00592 00595 00597 00598 00599 00600 00602 00603 00604 00608 00611 00614 00618 00622 00623 00627 00628 00634 00639 00640 00645 00655 00659 00664 00665 00667 00668 00669 00670 00671 00672 00673 00674 00675 00676 00677 00678A 00679 00680 00686 00688 00689 00690 00691 00694 00696 00699 00700 00704 00705 00707 00708 00709 00712 00713 00714 B13080721 B13080722 00726 00727 B13090729 00730 00731 00732 00734 00735 00736 00737 00738 00742 00744 00749 00750 00751 00752 00753 00755 00756 00757 B13120763 B13120764 B13120766 B13120768…

FDA’s list runs to 6,144 characters. The first part is shown; the rest is on FDA’s record.

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

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

These words name no state.

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

The words say it went outside the United States too.

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Terminated, in FDA’s file.

“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”

openFDA, on “Terminated”, its enforcement report fields.

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

The firm began the recall on May 1, 2019.
FDA classified it on Jul 3, 2019.
FDA’s Enforcement Report published it on Jul 10, 2019.
FDA terminated it on Jan 19, 2021.

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

Medtronic Navigation, Inc.-Littleton, of Littleton, MA.
Who began it, in FDA’s words: Voluntary: Firm initiated.
How the firm first told its customers: Letter.

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
Whether anyone was hurt or fell ill: the report doesn’t say.
How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
FDA’s list of codes runs to 6,144 characters; the first part is shown here, and the rest is on FDA’s record.
A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

U.S. Food and Drug Administration, Device recall enforcement reports.

Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

This record in openFDA

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.