Mobile Mini C-arm system Part # 1000-0004
Medical device recall Z-0259-2018. Published in FDA’s Enforcement Report on Jan 17, 2018.
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 Jan 17, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 2012 total 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?
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
2012 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number List: 5E1290 5H0178 5H0125 5E833 5E1164 5F0395 5E730 5E105 5H0126 5E921 5E742 5F0400 5E756 5E0940 5H0130 5F0126 5F0282 5F0412 5E763 5E0943 5H0151 5F0229 5H0273 5F0441 5E841 5E0961 5H0172 5F0230 5E0944 5F0449 5F0232 5E0981…
Every code shown here, 1,999 characters
Serial Number List: 5E1290 5H0178 5H0125 5E833 5E1164 5F0395 5E730 5E105 5H0126 5E921 5E742 5F0400 5E756 5E0940 5H0130 5F0126 5F0282 5F0412 5E763 5E0943 5H0151 5F0229 5H0273 5F0441 5E841 5E0961 5H0172 5F0230 5E0944 5F0449 5F0232 5E0981 5H0190 5F0387 5E0945 5F0451 5H0291 5E0982 5H0333 5F0445 5E0955 5F0456 5F0177 5E1009 5E0954 5F0453 5E1000 5F0468 5F0242 5E1042 5E1043 5F0457 5E1025 5F0471 5F0295 5E1051 5E1234 5F0465 5E1177 5F0482 5H0265 5E1063 5E1280 5F0610 5E1185 5F0495 5H0292 5E1080 5E908 5H0104 5E1225 5F0497 5E0938 5E1141 5F0158 5H0114 5E1249 5F0517 5E0990 5E1151 5F0408 5E1174 5E1265 5F0533 5E1021 5E1224 5F0519 5E1232 5E1276 5F0537 5E1032 5E1233 5H0272 5E846 5E1279 5F0548 5E1086 5E1266 5H0290 5E1137 5E1288 5F0594 5E1087 5E1269 5E0998 5E1257 5E734 5F0603 5E1105 5E1284 5E1033 5E1176 5E744 5F0621 5E1115 5E1293 5E1035 5E1178 5E772 5F0626 5E1150 5E1315 5E1047 5E1197 5E775 5F0630 5E1261 5E1316 5E1082 5E1303 5E818 5F0631 5E1287 5E739 5E1242 5E769 5E822 5F0632 5E1292 5E743 5E1289 5E794 5E843 5H0109 5E1299 5E761 5E1305 5E919 5E874 5H0116 5E1317 5E765 5E748 5F0188 5E875 5H0133 5E771 5E773 5F0378 5F0206 5E877 5H0137 5E792 5E782 5F0535 5F0207 5E883 5H0138 5E797 5E806 5H0352 5F0215 5E929 5H0139 5F0255 5E823 5H0354 5F0304 5F0112 5H0162 5F0273 5E860 5H0371 5F0416 5F0113 5H0173 5F0363 5E869 5E0964 5F0494 5F0118 5H0192 5F0474 5E893 5E1112 5F0506 5F0139 5H0193 5F0600 5E922 5E1179 5F0554 5F0140 5H0201 5F0618 5F0108 5E1246 5H0189 5F0221 5H0207 5F0620 5F0153 5E1301 5H0230 5F0331 5H0212 5F0625 5F0155 5E1302 5H0259 5F0467 5H0229 5F0633 5F0165 5E731 5H0260 5F0469 5H0232 5F0634 5F0173 5E746 5H0313 5F0518 5H0234 5H0106 5F0178 5E779 5H0361 5F0553 5H0237 5H0158 5F0199 5E800 5H0362 5H0161 5H0251 5H0231 5F0200 5E820 5E0988 5H0226 5H0252 5H0358 5F0211 5E839 5E1159 5H0246 5H0295 5E0937 5F0234 5F0216 5E1297 5H0296 5H0297 5E0992 5F0263 5F0320 5E732 5H0307 5H0302 5E1048 5F0264 5F0423 5E751 5H0312 5H0303 5E1066 5F0283 5F0523 5E816 5H0366 5H0304 5E1106 5F0290 5F0590 5E851 5E1133 5H0332 5E1123 5F0329…
FDA’s list runs to 3,422 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 - USA (nationwide) including Puerto Rico and Hawaii and to the countries of : Australia, Austria, Belgium, Canada, Dominican Republic, Estonia , Finland, France, Germany, Hanover, Hong Kong, Israel, Italy, Japan, Jonesboro, Korea, Malaysia. Netherland, New Zealand, Norway, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, UAE, and United Kingdom.
The states and territories these words name
- Hawaii
- Puerto Rico
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 Aug 31, 2017.
- FDA classified it on Jan 9, 2018.
- FDA’s Enforcement Report published it on Jan 17, 2018.
- FDA terminated it on Apr 21, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Orthoscan, Inc., of Scottsdale, AZ.
- Who began it, in FDA’s words: FDA Mandated.
- 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 3,422 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.
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.