FDA Medical Device Recalls (openFDA)
Maquet Medical Systems USA: Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
- Recall number
- Z-2140-2021
- Recalling firm
- Maquet Medical Systems USA
- Product
- Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
- Status
- Terminated
- Initiated
- 2021-07-14
- Posted
- not on file
- Terminated
- 2022-08-03
- Reason
- There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
- Root cause
- Device Design
- Action
- On July 14, 2021, Maquet Getinge Group issued Urgent Medical Device Recall notices to customers via FedEx 2 day Delivery with Signature Proof of Delivery. Customers were advised to take the following action: - Users should take the unit out of operation at the earliest opportunity and decommission the unit. - MCP has not developed a cleaning protocol that meets current concerns and expectations of the FDA. - If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. - Please acknowledge receipt of the Urgent Medical Device Recall by completing and returning the response form. Please either fax the completed form to (866) 5715830 or send via email to MCPHCU30.qrc@getinge.com.
- Quantity
- 33
- Distribution
- Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
- Lot, serial or model codes
- HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.
- 510(k) numbers
- ["K031544"]
- PMA numbers
- not on file
- Product code
- DWC
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
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