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Terminated

BrightView XCT Upgrade Model 882454

FDA Recall Z-2737-2016 · Posted None

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2016-05-25
Date Terminated2018-07-02
Product Quantity3 units

Reason for Recall

The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.

Firm Action

The firm is informing the consignee of this issue through Customer Information Letter.

Root Cause

Software design

Distribution Pattern

Worldwide distribution. US nationwide, Algeria, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Finland France, Gabon, Germany, Greece, India, Indonesia, Ireland, Japan, Korea, Republic of Korea, Republic of Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080927BRIGHTVIEW VCT IMAGING SYSTEMPhilips Medical Systems (Cleveland), Inc. · 2008-04-11

Official Source

View FDA Recall →

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

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