Reported Mar 19, 2014 · Terminated
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588.…
Clarity Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clarity Medical Systems Inc · 5775 W Las Positas Blvd Suite 200 · Pleasanton, CA · 94588-4084
Is this the product you have?
- RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
- Lot codes and dates
- no lot numbers
RetCam 3 (RC3Part number 21-100500
- Serial numbersRetCam Portable (RTP), Part number 23-00100
288 of 288 codes
RC3125RC6003RC6004RC6005RC6006RC6007RC6008RC6009RC6010RC6011RC6012RC6013RC6014RC6015RC6016RC6017RC6018RC6019RC6020RC6021RC6022RC6023RC6024RC6025RC6026RC6027RC6028RC6029RC6030RC6031RC6033RC6034RC6035RC6036RC6037RC6038RC6039RC6040RC6041RC6042RC6043RC6044RC6045RC6046RC6047RC6048RC6049RC6050RC6051RC6052RC6053RC6054RC6055RC6056RC6057RC6058RC6059RC6060RC6061RC6062
- serial numbersRetCam Shuttle (RCS), Part number 20-000300
RP6003RP6004RP6005RP6006RP6007RP6008RP6009RP6010RP6301RP6302RP6303RP6304RP6305RP6306RP6307RP6307RP6308RP6309RP6310RP6311RP6312RP6313RP6314
- Serial number
166 of 166 codes
RS3074RS6001RS6002RS6003RS6004RS6005RS6006RS6007RS6008RS6009RS6010RS6011RS6012RS6013RS6014RS6015RS6016RS6017RS6018RS6019RS6020RS6021RS6022RS6023RS6024RS6025RS6026RS6027RS6028RS6029RS6030RS6031RS6032RS6033RS6034RS6035RS6036RS6037RS6038RS6039RS6040RS6041RS6042RS6043RS6044RS6045RS6046RS6047RS6048RS6049RS6050RS6051RS6052RS6053RS6054RS6055RS6056RS6057RS6058RS6059
- no lot numbers
- Amount recalled
- 166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.
Where it was sold
Why it was recalled
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
This product could cause temporary or reversible health problems — stop using it.
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