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Trilogy Evo, all software versions except 1.05.06.00.… recallZ-1504-2024 · Philips Respironics, Inc. · initiated Mar 19, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Respironics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDA root cause category: Device Design

What the company is doing

Consignees were mailed an URGENT MEDICAL DEVICE CORRECTION notice, dated 3/7/24. Consignees are asked to identify any affected product in their inventory and follow the provided instructions in order to continue using devices safely in CPAP or PSV mode. Devices that alarm are to be immediately plugged into a power source if a Loss of Power Alarm occurs. If no source of power is available, remove and replace the detachable battery. Devices running on software other than 1.05.06.00 can be updated to the latest software version, which does not experience this failure mode. The provided recall notice should be shared with all members of consignee organizations that utilize the recalled devices. If product was further distributed the provided notice should be forwarded. Consignees with any questions can contact Philips Respironics Customer Service at 1-800-345-6443 for homecare customers or 1-800-722-9377 for hospital customers.

Recall details

Recall number
Z-1504-2024
Status
Open, Classified
Initiated by the company
Mar 19, 2024
Posted by the FDA
Apr 17, 2024
Recalling firm
Philips Respironics, Inc.
Quantity
76,713 units
Product code
CBK
FDA submissions
K181170
Distribution
Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, US, UY, VN, YT, ZA, ZW.

Product description

Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model No. AU2110X15B, BL2110X15B, BL2200X15B, BR2110X18B, BR2200X18B, CA2110X12B, CA2200X12B, DE2100X13B, DE2110X13B, DE2200X13B, DS2000X11B, DS2100X11B, DS2110X11B, DS2200X11B, EE2100X15B, EE2110X15B, EE2200X15B, ES2100X15B, ES2110X15B, ES2200X15B, EU2100X15B, EU2100X19, EU2110X15B, EU2110X19, EU2200X15B, FR2100X14B, FR2110X14B, FR2200X14B, FX2100X15B, FX2200X15B, GB2110X15B, GB2200X15B, IA2100X15B, IA2110X15B, IN2100X15B, IN2100X19, IN2110X15B, IN2200X15B, IT2100X21B, IT2110X21B, IT2200X21B, JP2100X16B, JP2110X16B, KR2110X15B, KR2200X15B, LA2100X15B, LA2110X15B, LD2110X23B, ND2100X15B, ND2110X15B, ND2200X15B, RDS2110X11B, SP2100X26B, TR2110X15B, TR2200X15B, UDS2110X11B, VT2110X24B; UDI-DI: 606959051980, 606959055520, 606959055476, 606959052307, 606959054110, 606959051942, 606959055544, 606959054080, 606959054981, 606959055537, 606959055506, 606959054127, 606959055490, 606959051959, 606959055421, 606959051973, 606959055483, 606959055452, 606959055513, 606959060517, 606959055551, 606959060500; All units except those with software version 1.05.06.00.

Devices named in this recall

17 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K181170 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94263).

Sources and updates

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