FDA event 84406 · Recall Observatory

device · product 1 of 13

Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0942-2020

Recall number: Z-0942-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 21

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: IN2110X15B Serial Numbers: H23502245F792, H257875388996, H2578757062BE, H25787599656F, H25787620F362, H25787645F01F, H25787664D226, H257876844836, H257877329374, H257877487126, H25787767BA61, H2578778054CE, H25793096DD8D, H2579309834F3, H25793099257A, H25793100357F, H25793102166D, H2579310307E4, H257970640FBB, H25797184CF77, H257992176BD2,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 2 of 13

Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0943-2020

Recall number: Z-0943-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 8

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: ES2110X15B Serial Numbers: H25123324AA45, H2512383941DE, H251239768495, H25124050192C, H251250171648, H25125051141E, H2512510467D7

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 3 of 13

Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0944-2020

Recall number: Z-0944-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 31

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: DE2110X13B Serial Numbers: H23708996882F, H24371560D579, H255384963A07, H2579305546B6, H2579306309E8, H23616736C469, H236241588BA4, H23626795164E, H23626844FD78, H236271027F8B, H236283633D93, H257930373174, H25793039D80A, H257930621861, H257930656CDE, H25793068B73B, H24740249E6D6, H24740326102D, H2474037887EB, H24740441BC47, H24740484424A, H24740639C8BF, H247408214D34, H247465944AD4, H247498926264, H24749940ABD2, H24750005F526, H247500934708, H24750114A7AB, H248213036E9A, H2497582673B2,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 4 of 13

Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0945-2020

Recall number: Z-0945-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 48

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: EU2110X15B Serial Numbers: H23570360C0F9, H236165266809, H236170100251, H2362652456D7, H2367778607E2, H23678062E52A, H247381064321, H2473940554BC, H24752480365C, H247526530107, H24752695CD91, H24758951B47C, H249175058F08, H24917512E26F, H24917524AD31, H24917525BCB8, H256248595EFE, H256275006735, H25635324F64A, H25689296BBF4, H25689940471C, H256243108DF9, H25633989E83F, H25688120C9B5, H256071177FBB, H25621714C6EB, H25630159BB48, H256340314BE0, H256340838C5A, H25637275FAD1, H25689361165F, H25689719B47E, H24739273AA5B, H2475250390DB, H24752553EE63, H247525835E1B, H247526623AE6, H247588091C50, H247588393638, H24762622404A, H249175049E81, H249175268E23, H25390193E59D, H2523550045AB, H256247295931, H25627287514F, H25637231DB95, H25690196A6B7,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 5 of 13

Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0946-2020

Recall number: Z-0946-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 105

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: LD2110X23B Serial Numbers: H239876824C6F, H239876835DE6, H23987688E335, H239876943081, H23987698FAED, H239877197F78, H23987731C080, H23987734972D, H240018521FDD, H24001858B087, H2400193657F5, H24739549A36C, H2473957014C5, H247401821EC1, H247406117747, H247407147A36, H2474074261B8, H24746531E009, H247467227EF2, H2474675675DE, H24750031996A, H24750050DC33, H24750144D913, H247522426A37, H2475230432BD, H24752527E54F, H247587538775, H247626140F14, H24801227575A, H2496106842C6, H249611989BD2, H249632560D1E, H24963287ACEF, H249633015DC5, H24970053C182, H2497182710D7, H249719471EDB, H249720843C33, H249724955703, H249891402382, H24999893363B, H251260919873, H25230803E618, H252308867F75, H25230916F2B1, H25230960DA8F, H252309795E96, H25231040699A, H2523105161CB, H252310650D87, H25231134386A, H252311723A3C, H25233073481F, H252330743CA0, H252330752D29, H252330761FB2, H252330770E3B, H25233078F6CC, H25233083CBD7, H25233084BF68, H25233085AEE1, H25233092C386, H25233094A6B0, H25233095B739, H25233097942B, H252331006D50, H252331060866, H252331107488, H25233112579A, H2523311432AC, H252331170037, H25233119E949, H252331205EE0, H252331214F69, H252331227DF2, H25233125094D, H252331263BD6, H252331272A5F, H25233129C321, H252331304738, H2523313156B1, H2523313375A3, H25233139DAF9, H252331466F06, H25235209546F, H25235233D15D, H2523527084A6, H252353009372, H252353108AAA, H25235326C5F4, H252354246AE3, H25235432160D, H2523547360E4, H252356192ED6, H25235633B23C, H25235651C5FE, H25235661EF96, H252356907DD7, H25235714AFEF, H25390190D706, H25390192F414, H253901949122, H2539019580AB, H25390196B230, H25904803A41D,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 6 of 13

Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0947-2020

Recall number: Z-0947-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 15

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: GB2110X15B Serial Numbers: H24736983B2CC, H247625953F39, H24999941FF8D, H251261507A86, H251283213DFD, H251283452F09, H25128825527F, H25128931575F, H251291825B15, H25129198ED97, H255930567C7B, H256003738FD6, H25621580E26F, H256243863FD7, H25630201A6DC,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 7 of 13

Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0948-2020

Recall number: Z-0948-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 16

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: ND2110X15B Serial Numbers: H251017836F15, H2523309685A2, H252331351095, H252353329A08, H25504805F0DF, H255049394A07, H2550648781D8, H255065746A57, H25506638283F, H25506755FDD6, H255068597D7D, H25523364DD89, H255249956B93, H25524999A1FF, H2569010452BD, H2569170852B3,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 8 of 13

Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0949-2020

Recall number: Z-0949-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 5

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: FR2110X14B Serial Numbers: H248213027F13, H249718745CF4, H252330869C7A, H252331053AFD, H255249974881,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 9 of 13

Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0950-2020

Recall number: Z-0950-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 21

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: IN2100X15B Serial Numbers: H256063834784, H256063861029, H25606388F957, H256063953B6A, H2560640471FE, H2560640652EC, H25606409AA1B, H25772356E64A, H25841702B83F, H257725232A36, H257726780539, H257553668D8B, H2577229704BF, H257724106819, H257724646335, H25772518BE8D, H2577253775CA, H2577255055A5, H258161389AA1, H258416397658, H25841726CDAB,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 10 of 13

Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0951-2020

Recall number: Z-0951-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 3

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: IT2100X21B Serial Numbers: H24371481043C, H243714900C6D, H24371504C78D,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 11 of 13

Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0952-2020

Recall number: Z-0952-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 1

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: ES2100X15B Serial Numbers: H24371562F66B

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 12 of 13

Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0953-2020

Recall number: Z-0953-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 27

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: EU2100X15B Serial Numbers: H23987675BB18, H243715497B08, H243715587359, H2476245817A0, H255250576184, H2552506568FE, H25538501C37C, H25538516AE1B, H25538554EA69, H255386102449, H25538612075B, H255386332562, H2553865152A0, H256064131C99, H256064175ABD, H2560642115E3, H2560642336F1, H25781710C84C, H2578205663D2, H257821415469, H2578217429AC, H25787398A23F, H257930893CA2, H255384784969, H25538507A64A, H247624629292, H257872183623,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

device · product 13 of 13

LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

Z-0954-2020

Recall number: Z-0954-2020
Initiated: November 19, 2019
Classification: Class I
Status: Terminated
Recalling firm: Philips Respironics, Inc.
Quantity: 29

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected result failing requirements TSRS1298 and PRD439.

Code information

Model/Material Number: SP2100X26B Serial Numbers: H25538574D9D9, H256917933B78, H2569193868C0, H2569196907F1, H25691987749F, H256920522A99, H2569224829A3, H256924542CCE, H256925062BB8, H25692591881F, H25692661E4B3, H25692712C1FC, H25692910F2F5, H25692952B687, H256930400CE8, H25693118A4C4, H2569421090C9, H256943094E0C, H25755370F165, H25755371E0EC, H25755372D277, H25769443EF6B, H2576945959E9, H2576949608BE, H25769512DA86, H25769515AE39, H257695178D2B, H257699654692, H25772204E13C,

Distribution pattern

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

Event summary

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Every recalled product in this event

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