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Terminated

Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520

FDA Recall Z-0381-2008 · Posted 2007-12-01

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2007-03-23
Date Terminated2011-02-11
Product Quantity117 units

Reason for Recall

Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.

Firm Action

The firm has issued a Customer Safety Advisory Notice dated 12/6/2006, to all sites that have the pre-R2.0 OPTIVUE Flat Panel Positioners installed. Users will have a new microswitch-based collision detection system, installed free of charge.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution- USA including MA, ME, NJ, NY, PA, MD, WV, NC, SC, GA, FL, AL, TN, KY, OH, IN, MI, IA, WI, SD, ND, MT, IL, NE, LA, OK, TX, WY, NV, CA, AK AND AR, and countries of Serbia, Australia, Austria, Belgium, Canada, Denmark, El Salvador, France, Germany, Hungary, India, Ireland, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, China, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, Ukraine, UK.

Official Source

View FDA Recall →

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

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