Constellation Vision System, Model: Constellation XT, Catalogue Number: 8065751548 The Constellation Vision System is an
FDA device recall Z-1927-2010 · posted 2010-07-13 · Terminated
Recall details
- Recalling firm
- Alcon Research LTD dba Alcon Laboratories, Inc.
- Reason for recall
- Alcon identified system performance and machine settings that may impact the infusion performance of the CONSTELLATION Vision System, causing unexpected shut down, unresponsive touch screens, and fluidics issues.
- Action taken
- The firm, Alcon, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 2, 2010, along with training material to all customers. The letter informed the customers of the problem and indicated that Alcon Surgical Sales representative will be contacting them in the near future to follow-up on this training material and to answer any questions you may have. Alcon informed the customers that this action will not require removal of the CONSTELLATION Vision System from their facility. The letter also informed the customers that their Alcon Technical Customer Service Representative will be contacting them when we are authorized to provide you with the software and hardware updates for your system. For assistance and questions regarding the CONSTELLATION Vision System, customers were told they may contact their Alcon Surgical Sales Representative or Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 824 units total
- Distribution
- Worldwide distribution.
- Date initiated
- 2010-04-30
- Date posted
- 2010-07-13
- Date terminated
- 2011-09-19
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALCON VISION SYSTEM (K063583) | Alcon | 2008-05-09 |