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Terminated

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

FDA Recall Z-1224-2012 · Posted 2012-03-29

Recalling FirmHamamatsu Corporation
Recall StatusTerminated
Product CodeRBS
Date Initiated2011-03-30
Date Terminated2018-01-29
Product Quantity100

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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