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Recall Observatory FDA recall evidence

Device product

Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.

Z-1584-2016

March 11, 2016

Class II

Product summary

Firm
RESEARCH INSTRUMENTS LTD - SITE B
Event
Event 73581
Status
Terminated
Classification
Class II
Quantity
380 units
Official record key
device-enforcement:Z-1584-2016

Official wording

Reason: The units have been fitted with a potentially faulty power supply cable.

Code information: Serial numbers: 2-381

Distribution pattern: Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria, Australia, Austria, Bahrain, Belgium, British Virgin Islands, Bulgaria, Canada, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Nigeria, Norway, Pakistan, Peru, Poland, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, United Kingdom, and Vietnam,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The units have been fitted with a potentially faulty power supply cable.