• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Philips V60 Ventilators

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall Philips V60 Ventilators see related information
Date Initiated by Firm April 24, 2017
Create Date May 18, 2017
Recall Status1 Open3, Classified
Recall Number Z-2061-2017
Recall Event ID 77084
510(K)Number K082660  K102985  
Product Classification Ventilator, continuous, minimal ventilatory support,facility use - Product Code MNT
Product Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617.

Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.
Code Information , 100068378, 100069509, 100069510, 100069511, 100069516, 100069517, 100069519, 100069522, 100069611, 100069699, 100069745, 100069865, 100069957, 100069959, 100069960, 100069961, 100069962, 100069963, 100069964, 100069966, 100069967, 100069969, 100069986, 100069987, 100069989, 100069990, 100069991, 100069992, 100069993, 100069994, 100069995, 100070235, 100070237, 100070238, 100070239, 100070241, 100070242, 100070244, 100070245, 100070246, 100070247, 100070296, 100070297, 100070298, 100070299, 100070300, 100070302, 100070303, 100070304, 100070564, 100070565, 100070566, 100070568, 100070571, 100071390, 100071516, 100071521, 100071596, 100071864, 100071868, 100071871, 100071872, 100071873, 100071878, 100071921, 100071922, 100071923, 100071924, 100071925, 100071926, 100071927, 100071928, 100071929, 100071930, 100071960, 100071961, 100071962, 100071963, 100071964, 100071965, 100071966, 100071967, 100071968, 100071969, 100071970, 100071971, 100071972, 100071973, 100071974, 100071975, 100071976, 100071977, 100072013, 100072014, 100072015, 100072016, 100072017, 100072018, 100072019, 100072020, 100072021, 100072022, 100072023, 100072024, 100072025, 100072026, 100072027, 100072028, 100072029, 100072031, 100072032, 100072047, 100072048, 100072049, 100072050, 100072051, 100072052, 100072053, 100072054, 100072055, 100072056, 100072057, 100072058, 100072059, 100072060, 100072061, 100072062, 100072063, 100072064, 100072113, 100072114, 100072116, 100072117, 100072118, 100072119, 100072121, 100072122, 100072123, 100072124, 100072125, 100072126, 100072128, 100072129, 100072130, 100072296, 100072407, 100072500, 100072567, 100072568, 100072569, 100073258, 100073260, 100075096, 100075366, 100075374, 100075376, 100075393, 100075394, 100075397, 100075399, 100075400, 100075401, 100075403, 100075404, 100075405, 100075406, 100075410, 100078371, 100078382, 100078383, 100078384, 100078386, 100078690, 100078695, 100078697, 100078698, 100078700, 100078701, 100078702, 100078703, 100078704, 100078705, 100078706, 100078707, 100078708, 100078709, 100078710, 100078711, 100078712, 100078713, 100078714, 100078715, 100078716, 100078717, 100078718, 100078719, 100078720, 100078721, 100078816, 100078817, 100078818, 100078819, 100078840, 100078841, 100078842, 100078843, 100078844, 100078845, 100078846, 100078847, 100078848, 100078849, 100078851, 100078852, 100078853, 100078854, 100078855, 100078856, 100078857, 100078858, 100078859, 100078860, 100078861, 100078862, 100078863, 100078864, 100078865, 100078866, 100078868, 100078869, 100078870, 100078963, 100078964, 100078965, 100078966, 100079371, 100079372, 100079373, 100079374, 100079375, 100079376, 100079377, 100079378, 100079379, 100079380, 100079381, 100079382, 100079383, 100079384, 100079385, 100079386, 100079388, 100079389, 100079559, 100079560, 100079561, 100079562, 100079563, 100079564, 100079565, 100079567, 100079568, 100079569, 100079570, 100079571, 100079572, 100079573, 100079574, 100079575, 100079576, 100079577, 100079578, 100079617, 100079618, 100079619, 100079701, 100079702, 100079703, 100079704, 100079705, 100079706, 100079707, 100079708, 100079709, 100079712, 100079714, 100079715, 100079716, 100079717, 100079718, 100079719, 100079720, 100079721, 100079723, 100079724, 100080281, 100080420, 100080551, 100080554, 100080555, 100080556, 100080557, 100080558, 100080562, 100080564, 100080565, 100080566, 100080702, 100081711, 100081713, 100081746, 100081747, 100081753, 100082466, 100083145, 100083146, 100083147, 100083148, 100083149, 100083150, 100083151, 100083152, 100083155, 100083157, 100083159, 100083160, 100083161, 100083162, 100083212, 100083214, 100083217, 100083218, 100083221, 100083229, 100083230, 100083231, 100083562, 100083568, 100083572, 100083575, 100083578, 100085085, 100085099, 100085340, 100085389, 100085399, 100085467, 100085468, 100085469, 100085470, 100085471, 100085472, 100085473, 100085475, 100085476, 100085483, 100085967, 100085968, 100085969, 100085970, 100085971, 100085972, 100085973, 10008
Recalling Firm/
Manufacturer
Respironics California Inc
2271 Cosmos Ct
Carlsbad CA 92011-1517
For Additional Information Contact Christopher D. Barnette
760-918-7300
Manufacturer Reason
for Recall
Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts data travelling through the cable during the high resistance event.
FDA Determined
Cause 2
Device Design
Action The firm, Philips, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 20, 2017 to its customers. The Customers letter inform them that Respironics California is recalling the Philips V60 Noninvasive Ventilators manufactured before 15 September 2015; that the recall is for all V60s with date of manufacture before 15 September 2015 and not for V60 Ventilators manufactured on or after 15 September 2015; of the recall reason, risk to health, how to identify devices subject to recall, and actions to be taken the customers. The customers were also instructed to complete and return the RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email to: recall.response@philips.com or fax to: 1-877-499-7223 or mail to: Philips Healthtech, Mailstop# 4202, 3000 Minuteman Road, Andover, MA 01810-1032. On 5/9/17, Respironics has revised customer notification letter and began sending it out to their customers. The update includes the following actions to be taken: "appropriately trained personnel may continue using the V60" and "ensure an alternative form of ventilation device is available at all times, including intra-hospital transport (e.g. manual ventilation bag)." Philips will contact each consignee to schedule an appointment for this recall. Philip Engineers will remediate any affected V60 ventilators at the site. If you have any questions, please contact the Head of Q & R at 760-918-1067 or donald.sherratt@philips.com.
Quantity in Commerce 30,516 units
Distribution Worldwide Distribution- US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran (Islamic Republic Of), Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Malta, Mexico, Monaco, Morocco, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province Of China, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
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 = MNT and Original Applicant = RESPIRONICS CALIFORNIA, INC.
-
-