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

FDA device recall Z-1224-2012 · posted 2012-03-29 · Terminated

Recall details

Recalling firm

Hamamatsu Corporation

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

RBS

Quantity affected

100

Distribution

Worldwide Distribution-- USA (nationwide) and the country of Canada.

Date initiated

2011-03-30

Date posted

2012-03-29

Date terminated

2018-01-29

Location

Bridgewater, NJ