The System is designed as a modular system with components that include an Overhead Tube Suspension with…
Medical device recall Z-0552-2024. Published in FDA’s Enforcement Report on Dec 20, 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 Dec 20, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 134 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?
GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.
134 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI 01001952781183561122100021DX3SS2200214HL, System ID 205620DEF1; UDI 01001952781183561122080021DX3SS2200165HL, System ID 205783DEF1; UDI 01001952781183561122100021DX3SS2200211HL, System ID 205387DEF1; UDI…
Every code shown here, 1,997 characters
UDI 01001952781183561122100021DX3SS2200214HL, System ID 205620DEF1; UDI 01001952781183561122080021DX3SS2200165HL, System ID 205783DEF1; UDI 01001952781183561122100021DX3SS2200211HL, System ID 205387DEF1; UDI 01001952781183561122110021DX3SS2200216HL, System ID 623ABZARRWTMPO; UDI 01001952781183561122120021DX3SS2300001HL, System ID 928263DEF1; UDI 01001952781183561123040021DX3SS2300103HL, System ID 520NOGTEMPO; UDI 01001952781183561122100021DX3SS2200210HL, System ID 602ABZSCOTTSTMPO; UDI 01001952781183561122110021DX3SS2200223HL, System ID 602ABZCNTRLTMPO; UDI 01001952781183561123030021DX3SS2300082HL, System ID 209324DEF1; UDI 01001952781183561123020021DX3SS2300046HL, System ID 209497DEF1; UDI 01001952781183561122080021DX3SS2200158HL, System ID 303827DEF1; UDI 01001952781183561123010021DX3SS2300030HL, System ID 970242DEF1; UDI 01001952781183561122080021DX3SS2200168HL, System ID 303457DEF1; UDI 01001952781183561122030021DX3SS2200047HL, System ID 860545TEMPO1; UDI 01001952781183561122030021DX3SS2200046HL, System ID 860545TEMPO2; UDI 01001952781183561122010021DX3SS2200013HL, System ID 203838TEMPO; UDI 01001952781183561122070021DX3SS2200117HL, System ID 860889TEMPO; UDI 01001952781183561123010021DX3SS2300013HL, System ID 202444DEF2; UDI 01001952781183561123040021DX3SS2300135HL, System ID 202877TEM1; UDI 01001952781183561123020021DX3SS2300039HL, System ID 813681DEF1; UDI 01001952780702651122030021DX3SS2200032HL, System ID AHMGCTEM1; UDI 01001952781183561123030021DX3SS2300098HL, System ID 305222DEF1; UDI 01001952781183561122110021DX3SS2200228HL, System ID 561495DEF1; UDI 01001952781183561123020021DX3SS2100173HL, System ID MDEDTEMPO; UDI 01001952781183561122120021DX3SS2200265HL, System ID 407530DEF1; UDI 01001952781183561123020021DX3SS2300041HL, System ID 863680TEMP; UDI 01001952781183561122080021DX3SS2200128HL, System ID 305DLTEMPO; UDI 01001952781183561122070021DX3SS2200113HL, System ID 904BURGRAD1; UDI 01001952781183561123050021DX3SS2300145HL, System ID 407269DEF1; UDI…
FDA’s list runs to 9,104 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.
US Nationwide distribution.
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.
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 Nov 7, 2023.
- FDA classified it on Dec 14, 2023.
- FDA’s Enforcement Report published it on Dec 20, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Hangwei Medical Systems, Co. LTD, of Beijing, China.
- 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 9,104 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
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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.