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Walcott Rx Products
Walcott Rx Product Inc · Model Rx6-035-1 · UDI-DI 00840285312401
5
510(k) clearances
22
Adverse events
2
Recalls
19
Facilities
Description
Fixation Ring
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-11-14 | Haag-Streit USA Inc | Currently there is a possibility, at the start of the perimetry examination, for the background illumination of the cupola not to turn on. If no illumination of cupola occurs, da |
| 2011-06-20 | Haag-Streit USA Inc | A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.