GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx
Medical device recall Z-1942-2013. Published in FDA’s Enforcement Report on Aug 21, 2013.
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 Aug 21, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 44 states named
- 458 (306 US; 152 OUS) 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?
GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic Drive Performance.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body pants with the patient sitting, standing, or lying in the prone or supine position. These devices are not intended for mammographic applications.
458 (306 US; 152 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial # 1028082 00000102856WK4 00001027044WK5 00001027046WK0 00001027160WK9 00001027162WK5 00001027164WK1 00001027174WK0 00001027446WK2 00001027449WK6 00001027526WK1 00001027570WK9 00001027739WK0 00001027881WK0 00001027897WK6…
Every code shown here, 1,997 characters
Serial # 1028082 00000102856WK4 00001027044WK5 00001027046WK0 00001027160WK9 00001027162WK5 00001027164WK1 00001027174WK0 00001027446WK2 00001027449WK6 00001027526WK1 00001027570WK9 00001027739WK0 00001027881WK0 00001027897WK6 00001027900WK8 00001027901WK6 00001027902WK4 00001027903WK2 00001027904WK0 00001027942WK0 00001028045WK1 00001028046WK9 00001028047WK7 00001028048WK5 00001028063WK4 00001028082WK4 00001028219WK2 00001028300WK0 00001028301WK8 00001028304WK2 00001028454WK5 00001028460WK2 00001028461WK0 00001028564WK1 00001028590WK6 00001028591WK4 00001028592WK2 00001028593WK0 00001028594WK8 00001028616WK9 00001028648WK2 00001028649WK0 00001028650WK8 00001028651WK6 00001028653WK2 00001028655WK7 00001028656WK5 00001028657WK3 00001028861WK1 00001028867WK8 00001028931WK2 00001028102WK0 00000102866WK4 00001028918WK9 00001027502WK2 00001027935WK4 00001028206WK9 00001028079WK0 00001028230WK9 00001028277WK0 00001028913WK0 00001027984WK2 00001027349WK8 00001027217WK7 00001027292WK0 00001028037WK8 00001027352WK2 00001027382WK9 00001027345WK6 00001027879WK4 00001028044WK4 00001028075WK8 00001027768WK9 00001027152WK6 00001028025WK3 00001027820WK8 00001027262WK3 00001027774WK7 00001028080WK8 00001028078WK2 00001027501WK4 00001027505WK5 00001028294WK5 00001027361WK3 00001028041WK0 00001028065WK9 00001027322WK5 00001027387WK8 00001027362WK1 00001027344WK9 00001027359WK7 00001028401WK6 00001028491WK7 00001027371WK2 00001028279WK6 00001028276WK2 00001028231WK7 00001028267WK1 00001028076WK6 00001027824WK0 00001027450WK4 00001027992WK5 00001027895WK0 00001027775WK4 00001027421WK5 00001027894WK3 00001027503WK0 00001027693WK9 00001028235WK8 00001028040WK2 00001028039WK4 00001028337WK2 00001027169WK0 00001027207WK8 00001027376WK1 00001027214WK4 00001027356WK3 00001027383WK7 00001027490WK0 00001027773WK9 00001027369WK6 00001027380WK3 00001027583WK2 00001028292WK9 00001028341WK4 00001028291WK1 00001028213WK5 00001027317WK5 00001028284WK6 00001028278WK8 00001027296WK1 00001028115WK2…
FDA’s list runs to 6,871 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 states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY; and countries of: Albania, Australia, Bahrain, Belgium, Canada, Chile, Czech Republic, Dominican Republic, France, Germany, Great Britain, Honduras, Hungary, Ireland, Israel, Italy, Japan, Korea, Kuwait, Netherlands, Nigeria, Norway, Romania, Saudi Arabia, Spain, United Arab Emirates and Venezuela.
The states and territories these words name
44 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Guam
- Iowa
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- New Hampshire
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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 7, 2012.
- FDA classified it on Aug 9, 2013.
- FDA’s Enforcement Report published it on Aug 21, 2013.
- FDA terminated it on Feb 4, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Visit.
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 6,871 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.