FDA Medical Device Recalls (openFDA)
LivaNova Deutschland GmbH: 3T Heater Cooler System, REF: 16-02-85
- Recall number
- Z-0073-2024
- Recalling firm
- LivaNova Deutschland GmbH
- Product
- 3T Heater Cooler System, REF: 16-02-85
- Status
- Open, Classified
- Initiated
- 2023-08-03
- Posted
- 2023-10-06
- Terminated
- not on file
- Reason
- The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.
- 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 LivaNova.FSCA@livanova.com 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
- 37 systems
- Distribution
- US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K191402"]
- PMA numbers
- not on file
- Product code
- DWC
- Firm FEI
- 3002808267
- Firm city
- Munich
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28