Z-0589-2016Class II

Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W

Name: Z-0589-2016 Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2015-11-13
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2015-11-13 / Terminated / root cause: design

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water... on 2015-11-13. FDA classified it as Class II and gives the reason as "Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0589-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-13
Posted: 2016-01-05
Terminated: 2017-04-07
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
Reason for recall: Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. This can shut down the compressor or the entire HCU 30 Type 2 unit.
Root cause tag: design
FDA root cause: Device Design
Action: MAQUET sent "Product Recall Urgent Medical Device Field Correction" notices and "Medical Device Field Correction Response Forms" dated 11/13/2015 via UPS to affected customers. The notification identified the issue and how to identify the affected unit. The notification instructed customers to always keep a replacement heater-cooler unit on standby in the event of a unit failure; complete the attached Field Correction Response form (fax to 1.973.629.1518 or email to [email protected]; and that they would be contacted by a representative of the Maquet Service Team to schedule an onsite service to determine if the power supply board in their HCU 30 Type 2 unit is affected adn replace the power supply board as necessary. If the customer had any questions they are instructed to contact their Maquet Service Representative or Maquet Technical Support at 1.888.627.8383 (Press option 3, followed by Option 1 and then option 1 again), Monday through Friday between the hours of 8:00 am and 5:00 pm.
Quantity in commerce: 100 Units (distributed in United States)
Distribution: United States Nationwide Distribution
Product codes and lots: HCU 30 Base Unit 100 - 120 V, Model Number 704629/70103.4371 HCU 30 Base Unit 200 - 240 V, Model Number 704631/70103.4642 HCU 30 Base Unit Canadian/US, Model Number 705501/70103.4653 Heater Cooler Unit 30 with Serial Number <93101480 The affected power supply boards have serial numbers less than 107006001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0589-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0589-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-05

Product code DWC

K031544Class IIHeater Cooler Unit, Model Hcu 30Jostra AB / cleared 2003-08-07

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)