CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
FDA Recall Z-1828-2026 · Posted 2026-04-17
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Recalling FirmIntegra LifeSciences Corp. (NeuroSciences)
Recall StatusOpen, Classified
Product CodeLFL
Date Initiated2026-03-06
Product Quantity78 units
Reason for Recall
Software issue that renders the touch screen unresponsive.
Firm Action
An URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION notice dated 3/6/26 was sent to consignees. The notice instructs consignees to restart systems when freeze to restore functionality of the touchscreen capabilities for 8 minutes; this action may be used multiple times. Integra's Service and Repair can provide remote support to disable and re-enable the write filter with Integra employees and/or Authorized service personnel. This will reset the console to provide approximately 28 days with no touchscreen issue. Integra Lifesciences Service Team will contact consignees within 5 to 10 business days to schedule correction of affected devices at no cost. Consignees with any questions can direct them to Customer Service by emailing [email protected] or by phone at 1-800-654-2873.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide - US Nationwide distribution in the states of MI & NY. The countries of Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands. Poland, Spain, Switzerland, Tunisia & United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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