Z-1224-2012

Hamamatsu Corporation, Bridgewater NJ 08807 Microfocus X-ray Source L8601 series, L9121 series (90kV type...

Name: Z-1224-2012 Hamamatsu Corporation, Bridgewater NJ 08807 Microfocus X-ray Source L8601 series, L9121 series (90kV type...
Creator: Hamamatsu Corporation
Published: 2011-03-30
License: https://open.fda.gov/license/

Hamamatsu Corp. / initiated 2011-03-30 / Terminated / root cause: software

FDA source

Hamamatsu Corporation began a recall of Hamamatsu Corporation, Bridgewater NJ 08807 Microfocus X-ray Source L8601 series, L9121 series (90kV type MICROFOCUS X-RAY SOURCE), L7901 series, and L8031... on 2011-03-30. The reason FDA records is "It was discovered that the Micro Focus X-ray Source could be experiencing software related problems that would allow the unit to exceed the maximum power setting that was set by the operator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1224-2012
Status: Terminated
Initiated: 2011-03-30
Posted: 2012-03-29
Terminated: 2018-01-29
Recalling firm: Hamamatsu Corp.
Product: Hamamatsu Corporation, Bridgewater NJ 08807 Microfocus X-ray Source L8601 series, L9121 series (90kV type MICROFOCUS X-RAY SOURCE), L7901 series, and L8031 series (100kV type MICROFOCUS x-ray source
Product code: RBS Industrial X-Ray
Reason for recall: It was discovered that the Micro Focus X-ray Source could be experiencing software related problems that would allow the unit to exceed the maximum power setting that was set by the operator.
Root cause tag: software
FDA root cause: Software design
Action: Hamamtsu Corporation sent a Warning letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. CDRH approves your CAP under the following conditions: 1. Hamamatsu is able to work with your manufacturer customers to assure the revised manual and new label are provided to your customers' end users. 2. Hamamatsu informs CDRH if you receive information which indicates this control defect has occurred. Relevant information includes direct communication from customers or through observation of excessive wear on returned x-ray tubes. For questions regarding this recall call 908-231-0960, ext 2300.
Quantity in commerce: 100
Distribution: Worldwide Distribution-- USA (nationwide) and the country of Canada.
Product codes and lots: Series L8601, L9121, L7901, and L8031

Product code RBS

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)