Z-2320-2015Class II

GE Optional Laser Centering Device X-ray generator

Name: Z-2320-2015 GE Optional Laser Centering Device X-ray generator
Creator: GE Inspection Technologies, LP
Published: 2014-11-10
License: https://open.fda.gov/license/

GE Inspection Technologies, LP / initiated 2014-11-10 / Terminated

FDA source

GE Inspection Technologies, LP began a recall of GE Optional Laser Centering Device X-ray generator on 2014-11-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2320-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-10
Posted: 2015-08-13
Terminated: 2017-02-01
Recalling firm: GE Inspection Technologies, LP
Product: GE Optional Laser Centering Device X-ray generator.
Product code: RER Alignment Laser Product
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.
FDA root cause: Radiation Control for Health and Safety Act
Action: GE's Planned Action for repair: 1. Replacement compliant laser centering devices will be shipped to purchasers, with prepaid shipping envelopes for purchasers to return the noncompliant units to GE. 2.All mailings will be made at no cost to the purchaser; and 3.The corrections will be completed by November 1, 2015 Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification. For further questions please call (717) 447-1278.
Quantity in commerce: 25
Distribution: US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.
Product codes and lots: Model No. 025.03.00A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2320-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2320-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-13

Product code RER

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)