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U.S. Department of Health and Human Services

Class 2 Device Recall Capnostream20 M NICU (CPM)

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  Class 2 Device Recall Capnostream20 M NICU (CPM) see related information
Date Initiated by Firm July 31, 2018
Create Date October 03, 2018
Recall Status1 Terminated 3 on September 20, 2022
Recall Number Z-0046-2019
Recall Event ID 80895
Product Classification Oximeter - Product Code DQA
Product Capnostream20 M NICU (CPM), CS08654RN
Code Information B300001035 B300001077 B300001081 B300001085 B300001086 B300001088 B300001054 B300001067 B300001073 B300001087 B300001026 B300001041 B300001058 B300001062 B300001078 B300001079 B300001080 B300001083 B300001084 B300001089 B300001090 B300001091 B300001173 B300001175. B300001217 B300001055 B300001059 B300001134 B300001143 B300001150 B300001151 B300001152 B300001157 B300001174 B300001175 B300001194 B300001197 B300001199 B300001206 B300001209 B300001211 B300001223 B300001225 B300001149 B300001226 B300001227 B300001072 B300001093 B300001153 B300001154 B300001186 B300001192 B300001221 B300001155 B300001156 B300001193 B300001222 B300001305 B300001338 B300001340 B300001345 B300001346 B300001347 B300001348 B300001349 B300001350 B300001353 B300001358 B300001365 B300001367 B300001369 B300001371 B300001374 B300001379 B300001380 B300001382 B300001390 B300001391 B300001401 B300001406 B300001213 B300001240 B300001378 B300001413 B300001414 B300001415 B300001416 B300001417 B300001419 B300001420 B300001421 B300001424 B300001426 B300001428 B300001429 B300001431 B300001434 B300001435 B300001436 B300001437 B300001438 B300001440 B300001442 B300001444 B300001447 B300001451 B300001457 B300001463 B300001433 B500001557 B500001536 B500001560 B500001564 B300001159 B300001243 B300001272 B300001279 B300001357 B300001361 B300001368 B300001376 B300001381 B300001385 B300001395 B300001499 B300001196 B300001322 B300001329 B300001333 B300001337 B300001351 B300001356 B300001387 B300001403 B500001480 B500001483 B300001286 B300001306 B300001307 B300001410 B300001411 B500001597 B500001598 B500001599 B500001600 B500001601 B500001603 B500001604 B500001605 B500001606 B500001608 B500001609 B500001610 B500001611 B500001612 B500001613 B500001614 B500001615 B500001616 B500001617 B500001618 B500001619 B500001620 B500001621 B500001622 B500001623 B500001624 B500001625 B500001626 B500001627 B500001628 B500001629 B500001630 B500001631 B500001632 B500001633 B500001634 B500001635 B500001636 B500001637 B500001638 B500001639 B500001640 B500001641 B500001642 B500001643 B500001645 B500001646 B500001928 B500001946 B500001977 B500001985 B500002009 B500001919 B500001955 B500001929 B500001980 B500001917 B500001918 B500001931 B500001964 B500002021 B500002041 B500002063 B500002065 B500002067 B500002068 B500002069 B500002075 B500002076 B500001938 B500001956 B500002017 B500002018 B500002029 B500002057 B500002058 B500002061 B500002064 B500002070 B500002071 B500002077 B500002079 B500002080 B500001730 B500001951 B500002011 B500002013 B500002016 B500002019 B500002020 B500002024 B500002025 B500002026 B500002027 B500002030 B500002031 B500002032 B500002033 B500002035 B500002036 B500002037 B500002038 B500002039 B500002040 B500002045 B500002047 B500002053 B500002055 B500002059 B500002081 B500002564 B500002599 B500002614 B500002529 B500002595 B500002597 B500002598 B500002600 B542112912 B542112914 B543123478 
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 2		 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 262
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.
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