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U.S. Department of Health and Human Services

Class 1 Device Recall V60 Ventilator

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 Class 1 Device Recall V60 Ventilator see related information
Date Posted June 17, 2013
Recall Status1 Terminated on April 24, 2014
Recall Number Z-1537-2013
Recall Event ID 65376
510(K)Number K082660  K102985 
Product Classification Ventilator, continuous, minimal ventilatory support,facility use - Product Code MNT
Product Respironics V60 Ventilator, Model #V60

Respironics Material P/N (Philips 12 Digit P/N):

85008 (85008)
1053613 (989805628251)
1053614 (989805612101)
1053615 (989805613391)
1053616 (989805613661)
1053617 (989805611761)
1053618 (n/a)
R1053618 (n/a)
1076709 (n/a)
1076715 (989805627411)
1076716 (989805627431)
1076717 (989805627441)
DU1053617 (989805616411)
U1053614 (989805636441)
U1053617 (989805636631)

Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581.

The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
Code Information SS1144060
SS1144079
SS11323HD
SS11350CE
SS11323CY
SS11310U1
SS11153P2
SS11490UC
SS11061RJ
SS11390WM
SS113909A
SS11490WF
SS11491HT
SS1139030
SS1139038
SS113903F
SS113906P
SS113906T
SS113906X
SS1139076
SS1139086
SS1139091
SS113909F
SS113909P
SS11390CY
SS11390H5
SS11390HV
SS1149167
SS114917T
SS11490V2
SS11491DH
SS112479W
SB12021MX
SS114911C
SB12021NX
SB12021N8
SS11490WW
SS11247DF
SB12021RU
SS11271HJ
SB12021T8
SB12021MN
SS1103069
SS11390FK
SB12021KR
SB120424K
SS11490XD
SB1204222
SB12041UB
SB12041W4
SB12021UM
SB12021SV
SS10410J9
SB120424J
SS11491H6
SB12041TA
SB12021ND
SB120420X
SS11390EA
SB120423Z
SB120424B
SB12041XE
SS11323R8
SS11323RN
SB12041YZ
SB12021PX
SS11323R9
SS11042T4
SB12041W3
SS11290W2
SB121110C
SB12111HC
SB12111FK
SS11271KF
SB12041WC
SB12110XA
SB12110WY
SB12090XX
SS11323NP
SB12111HX
SS11205W4
SB12021T9
SB12111EW
SB12041SV
SB12111FN
SB121119B
SB1209170
SB12111C2
SB12110XP
SB12110T9
SB121110S
SB12110XN
SB12110ZR
SB12110U5
SB12110WZ
SB12110WM
SB121719F
SB121117R
SB12111B2
SB12111BS
SB12111B7
SB121719X
SB12110XJ
SB1204215
SB12171H4
SB121914B
SB1219152
SB121919P
SB12110YK
SB1219119
SB121910N
SB121918W
SB121917J
SB121919D
SB12190XY
SS11491CJ
SB121917W
SB12212J5
SB12330RB
SB12330Y2
SB12330NF
SB12330PP
SB12330VY
SB12330X2
SB12330X8
SB123310P
SB123310Y
SB12340T8
SB12340TX
SB123414E
SB123414M
SB123414P
SB123414X
SB123416P
SB123416U
SB123418H
SB123418M
SB12341CN
SB12341DB
SB12341E4
SB12330M7
SB12330MX
SB12330PF
SB12330R8
SB12330S5
SB12330UN
SB12330YU
SB123310F
SB12330NS
SB12330V3
SB12330VD
SB1233105
SB12341DM
SS11491DM
SB12330UB
SB123700Y
SB1237020
SB123702P
SB123702W
SB1237053
SB123706H
SB1237093
SB123709A
SB123709R
SB12370A4
SB12390K3
SB1237012
SB1237038
SB123703M
SB123705R
SB1237078
SB1237083
SB123708E
SB123708H
SB123709H
SB12390JF
SB12390PH
SB12390RJ
SB12390JH
SB12390KJ
SB12390M4
SB12390M9
SB12390MP
SB12390N0
SB12390N1
SB12390N5
SB12390N6
SB12390P0
SB12390P3
SB12390P9
SB12390PF
SB12390R1
SB12390RM
SB12390RW
SB12390RY
SB12390SF
SB12390T2
SB12390TH
SB12390UA
SB12390V3
SB12390VC
SB12391BR
SB12450BW
SB12450C7
SS1025192
SS102519M
SB1243080
SB12450C1
SB12460MF
SB12450AR
SB12481X1
SB124821B
SB1248259
SB124826A
SB1248291
SB124829Y
SB12481VZ
SB12481W0
SB12481Z4
SB124821E
SB124822Z
SB1248246
SB12482A9
SB12482C5
SS092804Z
SS0928079
SS09280CZ
SS09280EA
SS09280ED
SS102517Z
SS102518R
SS10251AC
SS10251AY
SS10251C6
SS10251CX
SS10251DV
SS102901R
SS102902J
SS1029041
SS102905M
SS102906W
SS102907S
SB12481X0
SB12481Z8
SB12481ZD
SB124820A
SB124822F
SB124822T
SB1248242
SB1248255
SB124826J
SB124827V
SB124828E
SB124829K
SB12482AN
SB12482B6
SB12482BY
SB12482C7
SB1249152
SB1249161
SB124916W
SB1249179
SS093800T
SS101214A
SS10120ZF
SS11390TT
SS11491FA
SS093801B
SS093803S
SS093803U
SS093805T
SS0938061
SS093904V
SS0939014
SS093901P
SS0939010
SS093803B
SS093805U
SS093805Z
SS093806C
SS093806D
SS0938070
SS093807H
SS093904H
SS093904R
SS0939053
SS093904C
SS093806V
SS092802P
SS0928048
SS09280B3
SS09280CP
SS09280DU
SS0938043
SS093803Z
SS093801S
SS092001B
SS100400R
SS10120ZY
SS101213F
SS092808A
SS102200P
SS102201S
SS1022038
SS10120ZA
SS101212Z
SS1022036
SS1022049
SS1022058
SS10120Z0
SS101210K
SS1012132
SS1022005
SS1022020
SS102202S
SS102206T
SS102206W
SS102206Z
SS102207P
SS1022089
SS1012137
SS102201F
SS102200F
SS1022011
SS1022046
SS1022060
SS102206K
SS101210F
SS102203A
SS102203E
SS102204R
SS102204Z
SS102205M
SS102207A
SS1022080
SS1022007
SS1022045
SS102206N
SS102201W
SS1022027
SS102207M
SS102207R
SS1022002
SS1022012
SS102201A
SS102201T
SS102201V
SS1022023
SS1022025
SS1022033
SS102203Z
SS102204K
SS1022053
SS102205R
SS102207D
SS102207S
SS1022085
SS102208K
SS102208T
SS102208W
SS102208J
SS1022039
SS102204H
SS10220
Recalling Firm/
Manufacturer
Respironics California Inc
2271 Cosmos Ct
Carlsbad CA 92011-1517
For Additional Information Contact
760-918-7300
Manufacturer Reason
for Recall
Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.
FDA Determined
Cause 2
Software design
Action The firm, Philips Healthcare, sent a "MEDICAL DEVICE CORRECTION" letter dated June 3, 2013 to all customers who received the V60 Ventilators. The letter describes the product, problem identified and the actions to be taken. The customers were informed that the V60 ventilator may continue to be used in accordance with its directions for use, pending the completion of the update. In addition, the customers were instructed to refer to their manual for additional information on warnings. A Philips Field Service Engineer, Approved Sevice Provider or Distributor will be contacting the customers to schedule a no-cost update and replacement of the Power Management Board Assembly Software on all V60 ventilators shipped from the manufacturer prior to April 1, 2013. If you need any further information or support concerning this issue, contact your local Philips Respironics representative at (800) 722-9377.
Quantity in Commerce 19,200 units total (12,060 units in US)
Distribution Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt , Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Kenya, Kuwait, Lebanon, Libya, Malaysia, Malta, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Utd.Arab.Emir. and Vietnam.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MNT and Original Applicant = RESPIRONICS CALIFORNIA, INC.
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