Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellar
FDA device recall Z-0864-2015 · posted 2014-12-23 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
- Action taken
- Bausch & Lomb contacted customers by phone on November 4, 2014. Customers were informed of the conditions required for the device to malfunction. Customers were also notified that a software update to address the situation will be installed in their system within the next few weeks, and that the firm's service team will be scheduling a visit to each facility to install this software update. Customers were also told that in the meantime they may continue to use the device. For further questions please call (585) 338-6839.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- HQF
- Quantity affected
- 2
- Distribution
- Worldwide Distribution - USA Distribution including to the states of AL, CA, CT, FL, GA, HI, IL, IN, KS, MI, MN, MO, MS, NH, NY, OH, OK, PA, TX, WI and WV., and to the countries of Austria, Australia,
- Date initiated
- 2014-11-04
- Date posted
- 2014-12-23
- Date terminated
- 2017-03-23
- Location
- Saint Louis, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STELLARIS PC VISION ENHANCEMENT SYSTEM (K133486) | Bausch & Lomb | 2014-03-12 |