Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported February 15, 2023
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ge Medical Systems Israel, Functional Imaging recalled GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm… - a critical-severity action.
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm… was recalled by Ge Medical Systems Israel, Functional Imaging in February 15, 2023. Reason: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-th…. Check the official notice for the remedy. Verify recall #Z-1057-2023 with the FDA Devices before acting.
The recall
Ge Medical Systems Israel, Functional Imaging issued this critical-severity FDA Devices recall-A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-th….
- Critical
- severity level
- 86 units
- affected scope
- Class I
- classification
- February 15, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1057-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1057-2023) was formally reported on February 15, 2023, with the manufacturer initiating the action on December 19, 2022. It is classified under Critical severity (Class I), with a current status of Ongoing. Ge Medical Systems Israel, Functional Imaging is listed as the recalling firm, operating out of Tirat Carmel. Federal records list the affected scope as 86 units.
The documented reason for this recall is: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury. Distribution data in the federal record shows the product reached: Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Repub…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
86 units
Related Recalls
6
3 from same agency
Product description
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
Reason for recall
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1057-2023 |
| Date reported | February 15, 2023 |
| Date initiated | December 19, 2022 |
| Recalling firm | Ge Medical Systems Israel, Functional Imaging |
| Firm location | Tirat Carmel |
| Affected scope | 86 units |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1057-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System. Recalled by Ge Medical Systems Israel, Functional Imaging. Units affected: 86 units.
Why was this product recalled? ▼
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2023. Severity: Critical. Recall number: Z-1057-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1057-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 15, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.