Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. Haag-Streit U
FDA device recall Z-2964-2011 · posted 2011-08-09 · Terminated
Recall details
- Recalling firm
- Haag-Streit USA Inc
- Reason for recall
- A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000.
- Action taken
- Haag-Streit USA, Inc. sent an "Urgent Field Safety Notices" dated June 20, 2011 to all affected customers. The letter included a description of the affected product and problem. The firm instructed their customers to make sure all new and current templates are saved and upgrade to EyeSuite version i4.000. Customers are asked to complete and return the Software Update Verification Form. For additional information contact the Haag-Streit at (513) 398-3937.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- HJB
- Quantity affected
- 216
- Distribution
- Nationwide (USA) Distribution.
- Date initiated
- 2011-06-20
- Date posted
- 2011-08-09
- Date terminated
- 2013-03-08
- Location
- Mason, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LENSTAR, MODEL LS900 (K082891) | Haag-Streit AG | 2009-10-20 |