DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4
Medical device recall Z-1206-2023. Published in FDA’s Enforcement Report on Mar 8, 2023.
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 Mar 8, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 9 states named
- 72 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?
After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).
72 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 60889978621613 (Rayco) 60889978624188 (1049) US Serial Numbers: SP0763 50066 50082 50089 50135 50145 50143 50140D 50144 OUS serial numbers: SP0819 SP0687G2 SP0726 SP0746 SP0834 SP0837 S0001 S0170 S0698G2 1085 FS0564 S0578 S0744 SP0903…
Every code shown here, 600 characters
UDI: 60889978621613 (Rayco) 60889978624188 (1049) US Serial Numbers: SP0763 50066 50082 50089 50135 50145 50143 50140D 50144 OUS serial numbers: SP0819 SP0687G2 SP0726 SP0746 SP0834 SP0837 S0001 S0170 S0698G2 1085 FS0564 S0578 S0744 SP0903 SP0600 SP1035 SP0930 SP1007 SP1037 SP0772 S0934G2 S0639G2 S1020G2 S0118 S0135 S0134 S0165 S0167 S0168 S0181 S0800G2 S0784G2 S0811G2 S0832G2 S0826G2 S0822G2 S1038G2 S0678G2 S0619G2 S0636G2 S0641G2 S0643G2 S0701G2 S0738G2 S0758G2 S0760G2 S0673G2 S0785G2 S0842G2 S0860G2 S0863G2 S0888G2 S0973G2 S1105G2 S1048G2 S1073G2 S1004G2 S1110G2 S0791G2 S0941G2 SP0900 S0625
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 distribution in the states of California, Idaho, Illinois, Massachusetts, Minnesota, Nevada, North Carolina, Texas Wisconsin and the countries of Argentina, Australia, Brazil, China, Finland, France, INDIA, ITALY, Korea, Malaysia, Poland, Republic of Korea.
The states and territories these words name
- California
- Idaho
- Illinois
- Massachusetts
- Minnesota
- North Carolina
- Nevada
- Texas
- Wisconsin
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Jan 30, 2023.
- FDA classified it on Mar 2, 2023.
- FDA’s Enforcement Report published it on Mar 8, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Carestream Health, Inc., of Rochester, NY.
- 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.”
- 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
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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.