Z-0073-2024Class II

3T Heater Cooler System, REF: 16-02-85

Name: Z-0073-2024 3T Heater Cooler System, REF: 16-02-85
Creator: LivaNova Deutschland GmbH
Published: 2023-08-03
License: https://open.fda.gov/license/

LivaNova Deutschland GmbH / initiated 2023-08-03 / Open, Classified / root cause: labeling and UDI

FDA source

LivaNova Deutschland GmbH began a recall of 3T Heater Cooler System, REF: 16-02-85 on 2023-08-03. FDA classified it as Class II and gives the reason as "The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0073-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-03
Posted: 2023-10-06
Recalling firm: LivaNova Deutschland GmbH
Product: 3T Heater Cooler System, REF: 16-02-85
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On August 3, 2023 and August 28, 2023, LivaNova issued a "Urgent Medical Device Correction" notification to affected consignees via E-Mail. LivaNova asked consignees to take the following actions: With the help of Attachment 1 of this letter, identify the location of the 3T Heater- Cooler device(s) where there may be an incorrect QRG. 2. Dispose of only the Quick Reference Guide rev 22 (bound of laminated pages). A new copy of the quick reference guide will be delivered to your facility as soon as possible. 3. Check whether the maintenance schedule reported in OI section 6.2.1 was followed. A. In case YES: You do not need to take any further action and you can continue to use the 3T device according to the OI. B. In case NO, B.1. Replace the aerosol collection if needed (ref. OI section 5.7.2) B.2. Disinfect the water circuit (ref. OI section 6.4) B.3. Monitor the water quality (ref. OI section 6.5.2) B.4. Remove the system from service until you receive the results of the water quality monitoring. B.5. In the case of Acceptable bacteria and NTM count (ref OI section 6.5.2 paragraph 4) you can continue to use the 3T device according to the OI. B.6. In case of Unacceptable bacteria and NTM count (ref OI section 6.5.2 paragraph 4), keep the system out of service, and contact your hygiene officer and your authorized service technician. LivaNova can provide an optional Deep Cleaning service for the system free of charge. Please contact your service technician or sales representative to request this service. 4. Fill in and sign the Customer Response Form (Attachment 1), and return it by email to [email protected] or by hand to your LivaNova contact person, to confirm that you have received this letter, you have read and understood its content, you have disposed the incorrect copy and you have received the corrected QRG laminated cards. 6. Please ensure that this Medical Device Correction is communicated to all personnel within your organization who need to be
Quantity in commerce: 37 systems
Distribution: US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.
Product codes and lots: UDI: (01)04033817900528/ Serial Numbers: 20T31334, 20T31336, 20T31366, 20T31391, 20T31375, 20T31322, 20T31348, 20T31345, 20T31362, 20T31363, 20T31364, 20T31407, 20T31531, 20T31532, 20T31534, 20T31367, 20T31368, 20T31369, 20T31370, 20T31371, 20T31372, 20T31373, 20T31386, 20T31387, 20T31388, 20T31389, 20T31390, 20T31550, 20T31551, 20T31552, 20T31553, 20T31543, 20T31544, 20T31536, 20T31346, 20T31347, 20T31361, 20T31365

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0073-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0073-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06

Product code DWC

K191402Class IIHeater-Cooler System 3TLivanova Deutschland, GmbH / cleared 2020-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)