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Recall Observatory FDA recall evidence

Device product

Elekta Precise Treatment Table

Z-1238-2015

January 29, 2015

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 70458
Status
Terminated
Classification
Class II
Quantity
529 US 2951 Worldwide
Official record key
device-enforcement:Z-1238-2015

Official wording

Reason: It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.

Code information: Precise Treatment Table Serial Numbers: (124001-125803, 125807-880, 125883-899, 125902-917, 125920-949, 125952-963, 125966-1256453, 126158-170, 126174-208, 126212-230, 126232-261, 126269-281, 126293-309,123318-330, 126338-126373, 126375-397, 126400-133999, 213000+)

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution and to the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland and Syria.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.