Z-0654-2017Class II

The Hemotherm 400CE 115v, containing power board p/n 39945

Name: Z-0654-2017 The Hemotherm 400CE 115v, containing power board p/n 39945
Creator: Cincinnati Sub-Zero Products Inc
Published: 2016-11-07
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2016-11-07 / Terminated / root cause: manufacturing process

FDA source

Cincinnati Sub-Zero Products Inc began a recall of The Hemotherm 400CE 115v, containing power board p/n 39945 on 2016-11-07. FDA classified it as Class II and gives the reason as "The device may not maintain water flow or temperature control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0654-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-07
Posted: 2016-11-22
Terminated: 2017-02-22
Recalling firm: Gentherm Medical, LLC
Product: The Hemotherm 400CE 115v, containing power board p/n 39945
Product code: DWS Instruments, Surgical, Cardiovascular
Reason for recall: The device may not maintain water flow or temperature control.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Cincinnati Sub-Zero sent an Urgent Medical Device Correction letter date November 7, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm has notified all customers to discontinue use and contact CSZ. Upon receipt of the new board, immediately remove and discard the affected power board and replace it with the newly provided power board. The complete and return the customer response form. For further questions, please call (513) 772-8810
Quantity in commerce: 50
Distribution: US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.
Product codes and lots: 154-10360CE 163-10502CE 163-10512CE 163-10527CE 164-10537CE 163-10491CE 163-10503CE 163-10513CE 163-10528CE 164-10538CE 163-10493CE 163-10504CE 163-10514CE 163-10529CE 164-10539CE 163-10495CE 163-10505CE 163-10515CE 163-10530CE 164-10540CE 163-10496CE 163-10506CE 163-10521CE 164-10531CE 164-10543CE 163-10497CE 163-10507CE 163-10522CE 164-10532CE 164-10544CE 163-10498CE 163-10508CE 163-10523CE 164-10533CE 164-10545CE 163-10499CE 163-10509CE 163-10524CE 164-10534CE 164-10547CE 163-10500CE 163-10510CE 163-10525CE 164-10535CE 164-10548CE 163-10501CE 163-10511CE 163-10526CE 164-10536CE 164-10549CE

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0654-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0654-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-22

Product code DWS

K122813Class IIHemotherm Model 400Ce Cooler/heater SystemCincinnati Sub-Zero Products, Inc. / cleared 2012-12-18

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)