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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Detail

Product Description 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.
Recall Number Z-1154-2014
Classification Class II
Code Info no lot numbers: RetCam 3 (RC3, Part number 21-100500; Serial numbers: RC3125 RC6003 RC6004 RC6005 RC6006 RC6007 RC6008 RC6009 RC6010 RC6011 RC6012 RC6013 RC6014 RC6015 RC6016 RC6017 RC6018 RC6019 RC6020 RC6021 RC6022 RC6023 RC6024 RC6025 RC6026 RC6027 RC6028 RC6029 RC6030 RC6031 RC6033 RC6034 RC6035 RC6036 RC6037 RC6038 RC6039 RC6040 RC6041 RC6042 RC6043 RC6044 RC6045 RC6046 RC6047 RC6048 RC6049 RC6050 RC6051 RC6052 RC6053 RC6054 RC6055 RC6056 RC6057 RC6058 RC6059 RC6060 RC6061 RC6062 RC6063 RC6064 RC6065 RC6066 RC6067 RC6068 RC6069 RC6070 RC6071 RC6072 RC6073 RC6074 RC6075 RC6076 RC6077 RC6078 RC6079 RC6080 RC6081 RC6082 RC6083 RC6084 RC6085 RC6086 RC6087 RC6088 RC6089 RC6090 RC6091 RC6092 RC6093 RC6094 RC6095 RC6096 RC6097 RC6098 RC6099 RC6100 RC6101 RC6102 RC6103 RC6104 RC6105 RC6106 RC6107 RC6108 RC6109 RC6110 RC6111 RC6112 RC6113 RC6300 RC6301 RC6302 RC6303 RC6304 RC6305 RC6306 RC6307 RC6308 RC6309 RC6310 RC6311 RC6312 RC6313 RC6314 RC6315 RC6316 RC6317 RC6318 RC6319 RC6320 RC6321 RC6322 RC6323 RC6324 RC6325 RC6326 RC6327 RC6328 RC6329 RC6330 RC6331 RC6332 RC6333 RC6334 RC6335 RC6336 RC6337 RC6338 RC6339 RC6340 RC6341 RC6342 RC6343 RC6344 RC6345 RC6346 RC6347 RC6348 RC6349 RC6350 RC6351 RC6352 RC6353 RC6354 RC6355 RC6356 RC6357 RC6358 RC6359 RC6360 RC6361 RC6362 RC6363 RC6364 RC6365 RC6366 RC6367 RC6368 RC6369 RC6370 RC6371 RC6372 RC6373 RC6374 RC6375 RC6376 RC6377 RC6378 RC6379 RC6380 RC6381 RC6382 RC6383 RC6384 RC6385 RC6386 RC6387 RC6388 RC6389 RC6390 RC6391 RC6392 RC6393 RC6394 RC6395 RC6396 RC6397 RC6398 RC6399 RC6400 RC6401 RC6402 RC6403 RC6404 RC6405 RC6406 RC6407 RC6408 RC6410 RC6411 RC6412 RC6413 RC6414 RC6415 RC6416 RC6417 RC6418 RC6419 RC6420 RC6421 RC6422 RC6423 RC6424 RC6425 RC6426 RC6427 RC6428 RC6429 RC6430 RC6431 RC6432 RC6433 RC6434 RC6435 RC6436 RC6437 RC6438 RC6439 RC6440 RC6441 RC6442 RC6443 RC6444 RC6445 RC6446 RC6447 RC6448 RC6449 RC6450 RC6451 RC6452 RC6453 RC6454 RC6455 RC6456 RC6457 RC6458 RC6459 RC6460 RC6461 RC6462 RC6463 RC6464 RC6466 RC6467 RC6469 RC6470 RC6471 RC6472 RC6473 RC6474 RC6475 RC6476 RC6477 RC6480 RC6486 RetCam Portable (RTP), Part number 23-00100; serial numbers: RP6003 RP6004 RP6005 RP6006 RP6007 RP6008 RP6009 RP6010 RP6301 RP6302 RP6303 RP6304 RP6305 RP6306 RP6307 RP6307 RP6308 RP6309 RP6310 RP6311 RP6312 RP6313 RP6314 RetCam Shuttle (RCS), Part number 20-000300; Serial number: RS3074 RS6001 RS6002 RS6003 RS6004 RS6005 RS6006 RS6007 RS6008 RS6009 RS6010 RS6011 RS6012 RS6013 RS6014 RS6015 RS6016 RS6017 RS6018 RS6019 RS6020 RS6021 RS6022 RS6023 RS6024 RS6025 RS6026 RS6027 RS6028 RS6029 RS6030 RS6031 RS6032 RS6033 RS6034 RS6035 RS6036 RS6037 RS6038 RS6039 RS6040 RS6041 RS6042 RS6043 RS6044 RS6045 RS6046 RS6047 RS6048 RS6049 RS6050 RS6051 RS6052 RS6053 RS6054 RS6055 RS6056 RS6057 RS6058 RS6059 RS6060 RS6061 RS6062 RS6063 RS6064 RS6065 RS6066 RS6067 RS6068 RS6069 RS6070 RS6071 RS6301 RS6302 RS6303 RS6304 RS6305 RS6306 RS6307 RS6308 RS6309 RS6310 RS6311 RS6312 RS6313 RS6314 RS6315 RS6316 RS6317 RS6318 RS6319 RS6320 RS6321 RS6322 RS6323 RS6324 RS6325 RS6326 RS6327 RS6328 RS6329 RS6330 RS6331 RS6332 RS6333 RS6334 RS6335 RS6336 RS6337 RS6338 RS6339 RS6340 RS6341 RS6342 RS6343 RS6344 RS6345 RS6346 RS6347 RS6348 RS6349 RS6350 RS6352 RS6353 RS6354 RS6355 RS6356 RS6357 RS6358 RS6359 RS6360 RS6361 RS6362 RS6363 RS6364 RS6365 RS6366 RS6367 RS6368 RS6369 RS6370 RS6371 RS6372 RS6373 RS6374 RS6375 RS6376 RS6377 RS6378 RS6379 RS6380 RS6381 RS6382 RS6383 RS6384 RS6385 RS6386 RS6387 RS6388 RS6389 RS6390 RS6391 RS6392 RS6393 RS6394 RS6395.
Product Distributed Qty 166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.
Reason For Recall 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.

Event Detail

Event Id 67470
Product Type Devices
Status Ongoing
Recalling Firm Clarity Medical Systems Inc
City Pleasanton
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-24
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution-USA (nationwide) including DC and the states of NM, LA, CA, MI, PR, GA, MD, MT, AL, MA, NY, IL, OH, TX, VA, MI, FL, MO, KY, TN, CT, NJ, PA, UT, SD, OK, MS, and NC and the countries of Algeria, Australia, Austria, Bangladesh, Belarus, The Netherlands, Brazil, Bulgaria, Chile, China, Columbia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,India, Indonesia, Iran, United Kingdom, Israel, Italy, Kuwait, Lebanon, Malaysia, Mexico, Sweden, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Taiwan, Thailand, Turkey, UAE, Argentina, Uzbekistan, Oman, Canada, Germany, and Switzerland.