PlainRecalls
FDA Devices Verify with FDA Devices → Moderate Class II Terminated

GE Optional Laser Centering Device X-ray generator.

Reported: August 19, 2015 Initiated: November 10, 2014 #Z-2320-2015 25 units

GE Inspection Technologies, LP issued this FDA Devices recall on August 19, 2015. Classified as Moderate severity (Class II). Approximately 25 units are affected. The recall was issued because: 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…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

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 indicate 25 units are affected.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

25

Related Recalls

6

6 from same agency

Recall Progress (industry avg ~60%) 60.0%

Product Description

GE Optional Laser Centering Device X-ray generator.

Reason for 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 alignment laser centering device.

Details

Units Affected
25
Distribution
US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.
Location
Lewistown, PA

Recall Profile

Structured summary of the FDA Devices recall record
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
Units affected 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.

Scale of Impact

25 units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
GE Optional Laser Centering Device X-ray generator.. Recalled by GE Inspection Technologies, LP. Units affected: 25.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 19, 2015. Severity: Moderate. Recall number: Z-2320-2015.
Where was the recalled product distributed?
Distribution: US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2320-2015) 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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).