Severity
Moderate
FDA Devices recall · Reported August 19, 2015
GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.
Ge Inspection Technologies, LP recalled GE Optional Laser Centering Device X-ray generator. - a moderate-severity action.
GE Optional Laser Centering Device X-ray generator. was recalled by Ge Inspection Technologies, LP in August 19, 2015. Reason: GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the align…. Check the official notice for the remedy. Verify recall #Z-2320-2015 with the FDA Devices before acting.
The recall
Ge Inspection Technologies, LP issued this moderate-severity FDA Devices recall-GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the align….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2320-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2320-2015) was formally reported on August 19, 2015, with the manufacturer initiating the action on November 10, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Ge Inspection Technologies, LP is listed as the recalling firm, operating out of Lewistown, PA. Federal records list the affected scope as 25.
The documented reason for this recall is: GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device. Distribution data in the federal record shows the product reached: US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.. 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.
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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
25
Related Recalls
6
3 from same agency
GE Optional Laser Centering Device X-ray generator.
GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2320-2015 |
| Date reported | August 19, 2015 |
| Date initiated | November 10, 2014 |
| Recalling firm | Ge Inspection Technologies, LP |
| Firm location | Lewistown, PA |
| Affected scope | 25 |
| Distribution | US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA. |
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.
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.
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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 August 19, 2015. 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.