Class 2 Device Recall The Captus 4000e Thyroid Uptake system

• Date Initiated by Firm: March 03, 2020
• Date Posted: March 24, 2020
• Recall Status: Terminated on November 12, 2021
• Recall Number: Z-1564-2020
• Recall Event ID: 85237
• Product Classification: Probe, uptake, nuclear - Product Code IZD
• Product: Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
• Code Information: Serial Numbers: 940146 940124 940127 940134 940147 940110 940123 940117 940120 940105 940106 940115 940118 940136 940137 940114 940141 940142 940113 940148 940103 940121 940135 940150 940122 940128 940129 940109 940104 940119 940107 940145 940125 940126 940130 940131 940112 940149 940132 940108 940111 940116 940133 940144 940152 940153 940154 940155 Additional systems added as of 3/26/20: 940005 940065 940265 940317 940325 940370 940406 940514 940061 940368 940369 940375 940376 940484 940485 940486 940528 940200 940217 940522 940038 940044 940048 940059 940060 940066 940081 940084 940096 940151 940228 940229 940243 940271 940336 940337 940338 940355 940413 940431 940435 940451 940473 940300 940405 940148 940019 940020 940006 940435 940035 940145 940102 940157 940175 940261 940356 940358 940521 940164 940533 940189 940207 940314 940334 940386 940129 940062 940122 940218 940266 940327 940347 940348 940349 940350 940381 940407 940440 940442 940491 940492 940493 940494 940515 940516 940517 940076 940354 940388 940476 940477 940478 940534 940535 940186 940322 940342 940402 940453 940305 940392 940247 940335 940346 940028 940174 940267 940268 940272 940195 940204 940270 940332 940393 940207 940357 940213 940452 940001 940002 940003 940004 940007 940008 940009 940010 940011 940012 940013 940014 940015 940016 940017 940018 940021 940022 940023 940024 940025 940026 940027 940029 940030 940031 940032 940033 940034 940037 940039 940040 940041 940042 940043 940045 940046 940047 940050 940051 940052 940053 940054 940055 940056 940057 940058 940063 940064 940067 940068 940069 940070 940071 940072 940073 940074 940075 940077 940077 940078 940079 940080 940082 940083 940085 940086 940087 940088 940089 940090 940093 940094 940095 940097 940098 940099 940100 940101 940103 940104 940105 940106 940107 940108 940109 940110 940111 940112 940113 940114 940115 940116 940118 940119 940120 940121 940123 940124 940124 940125 940126 940127 940128 940129 940130 940131 940133 940134 940135 940136 940137 940141 940142 940144 940146 940147 940149 940150 940152 940153 940154 940155 940159 940160 940161 940162 940163 940165 940166 940167 940168 940169 940170 940171 940172 940176 940187 940188 940190 940191 940192 940193 940194 940196 940197 940198 940199 940201 940202 940203 940205 940206 940206 940212 940215 940216 940220 940221 940222 940223 940224 940225 940226 940227 940230 940231 940232 940233 940234 940235 940236 940237 940238 940239 940240 940241 940242 940244 940245 940246 940262 940263 940264 940269 940273 940274 940275 940276 940277 940278 940279 940280 940281 940293 940294 940295 940296 940297 940298 940299 940301 940302 940302 940303 940306 940307 940308 940309 940310 940311 940312 940313 940315 940316 940318 940319 940320 940321 940323 940324 940326 940328 940329 940330 940331 940333 940339 940340 940341 940343 940344 940345 940351 940352 940353 940359 940360 940361 940362 940363 940364 940365 940366 940367 940371 940372 940373 940374 940377 940378 940379 940380 940382 940383 940384 940385 940387 940389 940390 940391 940394 940395 940396 940397 940398 940399 940400 940401 940403 940404 940408 940409 940410 940411 940412 940414 940415 940416 940417 940418 940419 940420 940421 940422 940423 940424 940425 940426 940427 940428 940429 940430 940436 940437 940438 940439 940441 940443 940444 940445 940446 940447 940448 940449 940450 940454 940455 940456 940457 940458 940459 940460 940461 940462 940463 940464 940465 940466 940467 940468 940469 940470 940471 940472 940474 940475 940479 940480 940481 940482 940483 940487 940488 940489 940490 940511 940512 940513 940518 940519 940520 940523 940524 940525 940526 940527 940529 940530 940531 940532 940536 940537 940538 940539 940540 940541 940542 940543 940544 940545 940117
• Recalling Firm/ Manufacturer: Capintec Inc; 7 Vreeland Rd; Florham Park NJ 07932-1511
• For Additional Information Contact: Mary Anne Yusko; 2001-825-9500 Ext. 312
• Manufacturer Reason for Recall: It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator.
• FDA Determined Cause: Device Design
• Action: Important Captus 4000e Safety Notice, Action Required letters dated 3/3/20 were sent to customers. As a precautionary measure, Capintec is requesting customers, whose systems include collimators from the same batch, perform a simple safety inspection. A detailed and easy to follow inspection procedure is included. The inspection can be performed in a few minutes, and any defect would be easily identified. Please confirm completion of inspection process by completing the attached form (page 2) and return to Capintec, Inc. For additional assistance or information, email capintec.techsupport@capintec.com or call 1-800-631-3826 and request technical support. A REVISED March 26, 2020 TO EXTEND SERIAL NUMBER RANGE notification letter was sent to customers: In February 2019, Capintec received a complaint that a collimator fell from a Captus 4000e system. A second complaint of a similar nature was received in September 2019. After evaluation of the failed components, it is possible that the collimators had screw hole locations that were insufficiently tapped. It is believed that the failures occurred after impact to the arm. Both collimators are believed to have originated from the same batch. It is possible other collimators from this batch may have a similar defect. It is also possible that all other collimators from the same batch are without issue and functioning satisfactorily. As a precautionary measure, Capintec is requesting customers, whose systems include collimators from the same batch, perform a simple safety inspection. A detailed and easy to follow inspection procedure is included. The inspection can be performed in a few minutes, and any defect would be easily identified. Please confirm completion of inspection process by completing the attached form (page 2) and return to Capintec, Inc.For additional assistance or information, email capintec.techsupport@capintec.com or call 1-800-631-3826 and request technical support.
• Quantity in Commerce: 48 (481 additional units added 3/26/20)
• Distribution: Worldwide distribution. US Nationwide, Australia, Austria, Bangladesh, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Hong Kong, India, Israel, Italy, Korea, Malaysia, Pakistan, Philippines, Poland, Saudi Arabia, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK, and Vietnam. (list updated 3/26/2020)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.