Class 2 Device Recall Servoi

• Date Initiated by Firm: September 17, 2020
• Create Date: October 09, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0092-2021
• Recall Event ID: 86548
• 510(K)Number: K123149
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.
• Code Information: Lot 6487800 Serial numbers 95160 95283 95284 95285 95286 95287 95288 95289 95290 95291 95292 95293 95294 95295 95296 95297 95363 95364 95365 95366 95367 95368 95369 95370 95371 95372 95373 95374 95431 95432 95433 95374 95435 95436 95437 95438 95439 95440 95441 95442 95455 95456 95457 95458 95459 95460 95461 95462 95463 95464 95465 95466 95467 95468 95469 95470 95471 95472 95473 95474 95475 95476 95477 95478 95880 95881 95882 95883 95884 95885 95886 95887 95888 95889 95890 95891 95892 95893 95894 95895 95896 95897 95898 95899 95900 95901 95902 95903 95904 95905 95906 95907 95908 95909 95910 95911 95912 95913 95914 95915 95916 95917 95918 95919 95920 95921 95922 95923 95924 95925 95926 95927 95928 95929 95930 95931 95932 95933 95934 95935 95946 95947 96018 96019 96020 96021 96022 96023 96024 96025 96026 96027 96028 96029 96050 96051 96052 96053 96054 96055 96056 96057 96058 96059 96060 96061 96062 96063 96064 96065 96066 96067 96068 96069 96070 96071 96072 96073 96145 96146 96147 96148 96149 96150 96151 96152 96153 96154 96155 96156 96157 96158 96159 96160 96161 96162 96163 96164 96165 96166 96167 96168 96169 96170 96171 96172 96173 96174 96796 96797 96798 96799 96800 96801 96802 96803 96804 96885 96886 96887 96888 96889 96890 96891 96892 96893 96894 96895 96896 96897 96898 96899 96900 96901 96902 96903 96904 96905 96906 96907 96908 96909 96910 96911 96912 96913 96914 96915 96916 96917 96918 96919 96920 97045 97046 97047 97048 97049 97050 97051 97052 97053 97054 97055 97056 97057 97058 97059 97060 97061 97062 97063 97064 97065 97066 97067 97068 97069 97070 97071 97072 97073 97074 97075 97076 97077 97078 97079 97080 97149 97150 97151 97152 97153 97154 97155 97156 97157 97158 97159 97160 97161 97162 97163 97164 97165 97166 97167 97168 97169 97170 97171 97172 97173 97174 97175 97176 97177 97178 97179 97180 97181 97182 97183 97184 97185 97186 97187 97188 97189 97190 97191 97192 97193 97194 97195 97196 97197 97198 97199 97200 97201 97202 97203 97204 97205 97206 97207 97208 97209 97210 97211 97212 97213 97214 97215 97216 97217 97218 97219 97220 97519 97520 97521 97522 97523 97524 97525 97526 97527 97528 97529 97530 97531 97532 97533 97534 97535 97536 97537 97538 97539 97540 97541 97542 97543 97544 97545 97546 97547 97548 97549 97550 97551 97552 97553 97554 97555 97556 97557 97558 97559 97560 97561 97562 97563 97564 97565 97566 97567 97568 97569 97570 97571 97572 97573 97574 97575 97576 97577 97578 97579 97580 97581 97582 98318 98319 98321 98322 98323 98324 98325 98326 98327 98328 98329 98330 98331 98332 98333 98334 98335 98336 98337 98338 98339 98340 98341 98342 98343 98344
• Recalling Firm/ Manufacturer: Getinge Group Logistics America, LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• Manufacturer Reason for Recall: A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
• FDA Determined Cause: Device Design
• Action: On September __, 2020, the firm issued an Urgent Medical Device Recall letter to affected customers. Distributors were instructed to forward the information to all current and potential Servo-i Ventilator System users and biomedical staff within hospitals/facilities. Customers were asked to examine their inventory immediately to determine if they have any products with the listed serial numbers. For affected units, an alternate means of nebulization would need to be readily available and used until the unit correction can be performed by the Getinge Service Technician if nebulization via the Servo-i Aeroneb Nebulization module be required. Customers were also asked to complete and return the response form to the firm to acknowledge their receipt of the notification. If you have one or more affected systems, you will be contacted by a Getinge Service Representative to schedule on-site correction of your device as soon as an update kit is available. Affected devices will be corrected free of charge. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9438872 (select option 1, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). You may also call this number if you have any questions about this recall.
• Quantity in Commerce: 431 units
• Distribution: Domestic distribution to AZ CA GA IL MN MO NC NJ NY RI SC TX VA WI WV Foreign distributed to Bosnia and Herzegovina, Czech Republic, France, Germany, India, Indonesia, Iraq, Italy, Kenya, Republic of Korea, Lebanon, Libyan Arab Jamahiriya, Norway, Palestine, Peru, Qatar, Saudi Arabia,Slovakia, Sri Lanka, Sweden Thailand, Turkmenistan, Ukraine and United Arab Emirates.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = MAQUET CRITICAL CARE AB