Elekta Precise Treatment Table
Reported: March 25, 2015 Initiated: January 29, 2015 #Z-1238-2015
Product Description
Elekta Precise Treatment Table
Reason for Recall
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.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 529 US 2951 Worldwide
- Distribution
- 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.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Elekta Precise Treatment Table. Recalled by Elekta, Inc.. Units affected: 529 US 2951 Worldwide.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2015. Severity: Moderate. Recall number: Z-1238-2015.
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