CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
FDA device recall Z-1828-2026 · posted 2026-04-17 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Reason for recall
- Software issue that renders the touch screen unresponsive.
- Action taken
- 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 custsvcnj@integralife.com or by phone at 1-800-654-2873.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LFL
- Quantity affected
- 78 units
- Distribution
- 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, Switze
- Date initiated
- 2026-03-06
- Date posted
- 2026-04-17
- Location
- Princeton, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUSA Clarity Ultrasonic Surgical Aspirator System (K161882) | Integra LifeSciences Corporation | 2016-10-14 |