Class 2 Device Recall Capnostream20 (US) M W/PRINTER TO MASIMO

• Date Initiated by Firm: July 31, 2018
• Create Date: October 03, 2018
• Recall Status: Terminated on September 20, 2022
• Recall Number: Z-0031-2019
• Recall Event ID: 80895
• 510(K)Number: K082268
• Product Classification: Oximeter - Product Code DQA
• Product: Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
• Code Information: B500002176 B500002177 B500002186 B500002191 B500002192 B500002194 B500002199 B500002201 B500002202 B500002204 B500002205 B500002206 B500002207 B500002208 B500002209 B500002210 B500002211 B500002212 B500002213 B500002214 B500002215 B500002216 B500002217 B500002218 B500002219 B500002220 B500002224 B500002225 B500002228 B500002229 B500002233 B500002236 B500002239 B500002240 B500002241 B500002245 B500002249 B500002250 B500002251 B500002252 B500002256 B500002258 B500002259 B500002261 B500002262 B500002265 B500002269 B500002270 B500002271 B500002272 B500002273 B500002274 B500002276 B500002277 B500002278 B500002279 B500002280 B500002281 B500002282 B500002283 B500002284 B500002285 B500002286 B500002287 B500002288 B500002291 B500002292 B500002293 B500002294 B500002295 B500002297 B500002298 B500002300 B500002301 B500002170 B500002234 B500002260 B500002266 B500002267 B500002296 B500002350 B500002351 B500002352 B500002353 B500002355 B500002356 B500002358 B500002359 B500002360 B500002361 B500002362 B500002363 B500002365 B500002366 B500002369 B500002371 B500002372 B500002395 B500002409 B500002410 B500002413 B500002414 B500002417 B500002419 B500002420 B500002421 B500002422 B500002423 B500002424 B500002425 B500002427 B500002428 B500002433 B500002438 B500002441 B500002442 B500002445 B500002452 B500002453 B500002454 B500002457 B500002460 B500002462 B500002463 B500002263 B500002264 B500002268 B500002289 B500002290 B500002299 B500002357 B500002364 B500002429 B500002430 B500002431 B500002432 B500002435 B500002443 B500002446 B500002498 B500002503 B500002510 B500002524 B500002533 B500002551 B500002583 B500002590 B500002591 B500002593 B500002447 B500002513 B500002392 B500002436 B500002437 B500002451 B500002456 B500002461 B500002464 B500002466 B500002467 B500002468 B500002473 B500002475 B500002480 B500002483 B500002490 B500002492 B500002506 B500002514 B500002439 B500002440 B500002455 B500002465 B500002561 B500002562 B500002302 B500002617 B500002618 B500002619 B500002620 B500002621 B500002622 B500002623 B500002628 B500002629 B500002630 B500002631 B500002632 B500002635 B500002636 B500002637 B500002638 B500002639 B500002640 B500002641 B500002644 B500002645 B500002646 B500002648 B500002649 B500002650 B500002652 B500002653 B500002659 B500002660 B500002662 B500002663 B500002664 B500002667 B500002668 B500002671 B500002673 B500002674 B500002675 B500002680 B500002681 B500002682 B500002683 B500002685 B500002686 B500002687 B500002689 B500002693 B500002694 B500002697 B500002223 B501123034 B501123035 B501123037 B501123038 B501123040 B501123041 B501123043 B501123044 B501123047 B501123050 B501123053 B501123056 B501123059 B501123062 B501123066 B502123072 B502123082 B502123083 B502123086 B502123087 B502123089 B502123090 B502123093 B502123094 B502123096 B502123098 B502123099 B502123104 B502123105 B502123106 B500002222 B500002237 B500002242 B500002246 B500002275 B500002354 B500002478 B501123064 B502123088 B502123091 B502123095 B502123097 B502123100 B502123107 B502123109 B502123110 B502123111 B502123112 B502123113 B502123114 B502123115 B502123116 B502123117 B502123118 B502123119 B502123121 B502123122 B502123123 B503123124 B503123125 B551113028 B500002502 B521123172 B523123185 B523123190 B524123195 B539112861 B542112908 B542112913 B542112916 B542112917 B542112924 B542112936 B547112958 B547112963 B547112964 B547112973 B523123188 B523123191 B529123196 B530123200 B530123201 B530123203 B530123204 B530123205 B530123206 B530123207 B530123209 B530123210 B530123211 B530123212 B530123213 B530123214 B537123301 B537123302 B537123303 B537123304 B537123305 B537123306 B537123307 B537123309 B537123310 B537123311 B537123312 B537123313 B537123314 B537123315 B537123316 B537123317 B537123318 B537123319 B537123320 B537123322 B537123323 B537123324 B537123325 B537123326 B537123327 B537123328 B537123329 B537123330 B537123331 B537123332 B502123103 B530123216 B541123413 B541123414 B541123415 B541123416 B541123417 B541123418 B541123419 B541123420 B541123421 B541123422 B541123423 B541123424 B541123425 B541123427 B541123428 B541123429 B541123430 B541123431 B541123432 B542123433 B542123434 B542123436 B542123437 B542123438 B542123440 B542123442 B542123444 B542123445 B542123446 B542123448 B542123450 B542123451 B542123452 B542123453 B542123455 B542123456 B543123457 B543123459 B543123460 B543123461 B543123462 B543123463 B543123464 B543123466 B543123467 B543123468 B543123469 B543123470 B543123472
• Recalling Firm/ Manufacturer: Oridion Medical 1987 Ltd.; Har Hotzvim Industrial Park Box 45025; Har Hotzvim Industrial Park; Jerusalem Israel
• Manufacturer Reason for Recall: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Urgent Medical Device Correction notification letters dated 7/31/18 were distributed to customers. The letters included the following instructions for customers: Share this notification with all care environments where the Capnostream" 20 and Capnostream" 20p bedside patient monitors are used, particularly in the areas where nurse call may be enabled (general care floors). If your facility has distributed these bedside patient monitors to other persons or facilities, please promptly forward a copy of this letter to those recipients. Medtronic is recommending continued use of Capnostream" devices. Users should confirm that the date/time is accurately displayed. If the date/time requires reset, all user defined settings, such as alarms and nurse call, will also require reset until the software is updated. Please follow the instruction in the Operators Manual to set user-defined default settings. The Operators Manual is available at http://www.medtronic.com/covidien/enus/support/product-manuals.html, refer to the Institutional Settings section. Return the completed Acknowledgement and Receipt Form by fax or email even if you have no inventory. In October 2018, download the software update from the Medtronic website via the following link which includes directions on how to download and install the software: http://www.medtronic.com/covidien/en-us/support/patient-monitoring-equipmentsoftware-upgrades.html.
• Quantity in Commerce: 400
• Distribution: The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.
• 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.

• 510(K) Database: 510(K)s with Product Code = DQA and Original Applicant = ORIDION CAPNOGRAPHY, INC.