The Recall Desk
HighFDA (Devices)·Z-1374-2022·Announced 2022-07-20

Ventana HE 600 Automated Slide Preparer Recalled for Potential Electrical Fire Risk

Ventana Medical Systems is recalling 763 Ventana HE 600 automated slide preparer instruments used in laboratories worldwide due to potential fluid leaks that could cause electrical shorts and fire.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device with potential for electrical fire due to fluid leakage. The source text describes a theoretical risk without documented incidents or injuries, meeting the rubric criterion for High (3): risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ventana Medical Systems Inc is recalling 763 Ventana HE 600 System instruments—automated slide preparers designed for use in clinical and research laboratories. The recall affects all production lots (UDI/DI: 04015630976010).

According to the FDA, there is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire. This represents a potential electrical hazard within laboratory environments.

The affected instruments have been distributed throughout the United States and internationally, including Canada, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Argentina, Australia, Brazil, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Israel, Japan, Kuwait, Lebanon, Malaysia, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates, and Vietnam. Laboratories and healthcare facilities using this equipment should contact Ventana Medical Systems Inc for recall instructions and guidance.

The recalled product

Product
Ventana HE 600 System, automated slide preparer, for use in laboratories.
Manufacturer
Ventana Medical Systems Inc
Category
Medical Device — Laboratory Equipment
Hazard
  • electrical-short
  • fire-risk
  • fluid-leak

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All Lots
  • UDI/DI: 04015630976010

Distribution

Distributed in 40 states:

  • AL
  • AR
  • AZ
  • CA
  • CO
  • CT
  • DC
  • FL
  • GA
  • HI
  • IA
  • IL
  • IN
  • KS
  • KY
  • MA
  • MD
  • MI
  • MN
  • MO
  • MS
  • MT
  • NC
  • NE
  • NJ
  • NY
  • OH
  • OK
  • OR
  • PA
  • PR
  • SC
  • SD
  • TN
  • TX
  • UT
  • VA
  • WA
  • WI
  • WV

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