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U.S. Department of Health and Human Services

Class 2 Device Recall Neonatal Flow Sensor Cable

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  Class 2 Device Recall Neonatal Flow Sensor Cable see related information
Date Initiated by Firm June 28, 2018
Create Date August 08, 2018
Recall Status1 Terminated 3 on February 22, 2019
Recall Number Z-2738-2018
Recall Event ID 80458
510(K)Number K142679  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010.

The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.
Code Information Model Number1506-8600-000,  Serial Numbers: CBRX00981 CBRX00984 CBRX00985 CBRX00988 CBRX00990 CBRX00438 CBRX00368 CBRX00369 CBRX01033 CBRX01043 CBRX01044 CBRX01048 CBRX01052 CBRX00201 CBRX00208 CBRX00209 CBRX00210 CBRX00212 CBRX00213 CBRX00214 CBRX00215 CBRX00216 CBRX00217 CBRX00749 CBRX00750 CBRX01124 CBRX01131 CBRX01136 CBRX01160 CBRX01162 CBRX01163 CBRX01164 CBRX01165 CBRX01166 CBRX01169 CBRX01017 CBRX01042 CBRX01068 CBRX01069 CBRX01070 CBRX01071 CBRX01083 CBRX01090 CBRX01091 CBRX01097 CBRX01106 CBRX01107 CBRX01112 CBRX01115 CBRX01116 CBRX01117 CBRX01118 CBRX01122 CBRX01125 CBRX01126 CBRX01127 CBRX01128 CBRX01132 CBRX01133 CBRX01134 CBRX01135 CBRX01137 CBRX01151 CBRX01152 CBRX01159 CBRX00983 CBRX01061 CBRX01062 CBRX00266 CBRX00480 CBRX00484 CBRX00488 CBRX00490 CBRX00492 CBRX00346 CBRX00417 CBRX00418 CBRX00421 CBRX00444 CBRX00459 CBRX00505 CBRX00521 CBRX00534 CBRX00535 CBRX00548 CBRX00552 CBRX00553 CBRX00555 CBRX00570 CBRX00571 CBRX00587 CBRX00627 CBRX00629 CBRX00348 CBRX00349 CBRX00350 CBRX00365 CBRX00416 CBRX00471 CBRX00481 CBRX00485 CBRX00486 CBRX00487 CBRX00489 CBRX00510 CBRX00511 CBRX00512 CBRX00561 CBRX00562 CBRX00325 CBRX00326 CBRX00327 CBRX01167 CBRX00635 CBRX00203 CBRX00206 CBRX00222 CBRX00223 CBRX00224 CBRX00225 CBRX00226 CBRX00228 CBRX00229 CBRX00232 CBRX00253 CBRX00259 CBRX00260 CBRX00261 CBRX00642 CBRX01053 CBRX00359 CBRX00354 CBRX00367 CBRX00396 CBRW03703 CBRX00140 CBRX00155 CBRX00156 CBRX00158 CBRX00159 CBRX00160 CBRX00161 CBRX00162 CBRX00163 CBRX00164 CBRX00165 CBRX00166 CBRX00167 CBRX00168 CBRX00169 CBRX00171 CBRX00172 CBRX00176 CBRX00178 CBRX00179 CBRX00180 CBRX00181 CBRX00182 CBRX00183 CBRX00184 CBRX00185 CBRX00186 CBRX00187 CBRX00189 CBRX00191 CBRX00193 CBRX00194 CBRX00195 CBRX00199 CBRX00234 CBRX00267 CBRX00268 CBRX00270 CBRX00273 CBRX00277 CBRX00280 CBRX00281 CBRX00283 CBRX00286 CBRX00381 CBRX00393 CBRX00397 CBRX00399 CBRX00422 CBRX00427 CBRX00430 CBRX00432 CBRX00435 CBRX00463 CBRX00473 CBRX00476 CBRX00477 CBRX00478 CBRX00482 CBRX00493 CBRX00497 CBRX00501 CBRX00516 CBRX00596 CBRX00597 CBRX00599 CBRX00600 CBRX00638 CBRX00655 CBRX00656 CBRX00657 CBRX00658 CBRX00661 CBRX00664 CBRX00666 CBRX00667 CBRX00671 CBRX00677 CBRX00703 CBRX00711 CBRX00712 CBRX00713 CBRX00720 CBRX00721 CBRX00722 CBRX00723 CBRX00896 CBRX00899 CBRX00900 CBRX00901 CBRX00912 CBRX00913 CBRX00914 CBRX00919 CBRX00920 CBRX00921 CBRX00926 CBRX00927 CBRX00969 CBRX00970 CBRX00971 CBRX00993 CBRX00994 CBRX00995 CBRX00996 CBRX00997 CBRX00998 CBRX01000 CBRX01001 CBRX01002 CBRX01003 CBRX01004 CBRX01005 CBRX01006 CBRX01008 CBRX01009 CBRX00705 CBRX00714 CBRX00715 CBRX00747 CBRX00757 CBRX00765 CBRX00623 CBRX00626 CBRX00649 CBRX00650 CBRX00651 CBRX00652 CBRX00662 CBRX00663 CBRX00668 CBRX00669 CBRX00670 CBRX00673 CBRX00450 CBRX00451 CBRX00453 CBRX00462 CBRX00464 CBRX00465 CBRX00498 CBRX00499 CBRX00500 CBRX00502 CBRX00569 CBRX00572 CBRX01104 CBRX00908 CBRX00274 CBRX00282 CBRX00287 CBRX00361 CBRX00366 CBRX00376 CBRX00382 CBRX00737 CBRX00760 CBRX00767 CBRX00545 CBRX00547 CBRX00947 CBRX00948 CBRX00949 CBRX00950 CBRX00785 CBRX00786 CBRX00797 CBRX00188 CBRX00190 CBRX01040 CBRX00400 CBRX00312 CBRX00313 CBRX00886 CBRX00930 CBRX00755 CBRX00102 CBRX00200 CBRX00335 CBRX00339 CBRX00352 CBRX01264 CBRX01269 CBRX00680 CBRX00682 CBRX00687 CBRX00688 CBRX01249 CBRX01251 CBRX01255 CBRX01266 CBRX01268 CBRX01270 CBRX01277 CBRX01278 CBRX01282 CBRX01283 CBRX01284 CBRX01287 CBRX01290 CBRX01293 CBRX01294 CBRX01295 CBRX01298 CBRX01299 CBRX01022 CBRX00452 CBRX00474 CBRX00506 CBRX00589 CBRX00175 CBRX00202 CBRX00204 CBRX01244 CBRX01259 CBRX00907 CBRX00338 CBRX00358 CBRX00378 CBRX00371 CBRX00425 CBRX01093 CBRX01094 CBRX00357 CBRX00353 CBRX00436 CBRX00601 CBRX00603 CBRX00606 CBRX00607 CBRX00608 CBRX00625 CBRX00519 CBRX00522 CBRX01149 CBRX01155 CBRX01156 CBRX01168 CBRX01170 CBRX00257 CBRX00265 CBRX00275 CBRX00279 CBRX00621 CBRX00622 CBRX00676 CBRX00689 CBRX00706 CBRX00727 CBRX00739 CBRX00751  Model Number 1505-5604-000,  Serial Numbers: 5473124-1 5475131-1 5473274-1 5471291-2 5469052-2 5472210-1 5473192-1 5473943-3 5466481-1 5466360-2 5472842-1 5470666-1 5473198-1 5466642-1 5470881-1 5461218-1 5468985-1 5471539-1  Model Number 2080496-010,  Serial Numbers: 5473274-1 5471291-1 5469462-1 5469869-1 5471316-1 5473943-1 5473943-2 5467910-1 5466360-1 5468261-1 5468261-2 5472270-1 5467664-1 : 
Recalling Firm/
Manufacturer		 Datex-Ohmeda, Inc.
3030 Ohmeda Dr
Madison WI 53718-6704
For Additional Information Contact
608-221-1551
Manufacturer Reason
for Recall		 The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 6/28/2018 to its customers on 06/28/2018. The letter describes the product, problem and actions to be taken. The customers were instructed to complete and return the attached "Customer Response" for via email to Recall34092.NFSCable@ge.com. The firm requested the return of cables that lacked the connector housing. GE Healthcare will replace all affected products at no cost to you. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 417 units
Distribution Worldwide Distribution: US (nationwide) to: Washington, DC and countries of: Algeria, Bangladesh, Brazil, Chile, China, Colombia, Germany, Greece, Guatemala, Honduras, India, Indonesia, Iran, Iraq, Italy, Kenya, Lebanon, Malaysia, Maldives, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Tunisia, Turkey, United Arab Emirates, 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 = CBK and Original Applicant = Datex-Ohmeda, Inc.
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