Z-2238-2019Class I

Quantum Pump Console

Name: Z-2238-2019 Quantum Pump Console
Creator: Spectrum Medical Ltd.
Published: 2019-05-29
License: https://open.fda.gov/license/

Spectrum Medical Inc / initiated 2019-05-29 / Terminated / root cause: software

FDA source

Spectrum Medical Ltd. began a recall of Quantum Pump Console on 2019-05-29. FDA classified it as Class I and gives the reason as "Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2238-2019
Classification: Class I
Status: Terminated
Initiated: 2019-05-29
Posted: 2019-08-23
Terminated: 2020-08-21
Recalling firm: Spectrum Medical Inc
Product: Quantum Pump Console
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Root cause tag: software
FDA root cause: Software design
Action: Spectrum Medical notified customers on about 05/29/2019 via "URGENT FIELD SAFETY CORRECTION" letter. Customers were informed that Spectrum Medical is in the process of installing the most recent software update v6.2.3.16 to the Quantum Perfusion Systems, (Quantum Pump Console). This software update corrects an error that could potentially lead to power loss. All Quantum Perfusion Systems are in scope of this issue. Customers were instructed to be aware that user intervention may be necessary with continued use before the software update, assure that all users receive notice of this issue, confirm receipt of the Urgent Medical Device Correction by returning the customer response form, and a Spectrum Medical service team will contact each customer and arrange a time and date to update the systems with the most recent software update. Additionally, customers were instructed to notify all relevant personnel and to customers if the devices have been further distributed.
Quantity in commerce: 108 units (8 US, 100 OUS)
Distribution: US distribution to NY, OH, VA, WA. International distribution to the Netherlands.
Product codes and lots: Software version 6.2.1.9; Serial Numbers PH1000005, PH1000020, PH1000027, PH1000030, PH1000077, PH1000081, PH1000082, PH1000086, PH1000087, PH1000093, PH1000100, PH1000101, PH1000102, PH1000103, PH1000109, PH1000110, PH1000112, PH1000113, PH1000114, PH1000115, PH1000120, PH1000127, PH1000129, PH1000131, PH1000132, PH1000134, PH1000135, PH1000137, PH1000139, PH1000140, PH1000141, PH1000144, PH1000145, PH1000150, PH1000156, PH1000158, PH1000159, PH1000160, PH1000161, PH1000162, PH1000165, PH1000168, PH1000170, PH1000171, PH1000172, PH1000175, PH1000176, PH1000177, PH1000178, PH1000179, PH1000180, PH1000182, PH1000201, PH1000208, PH1000209, PH1000210, PH1000211, PH1000212, PH1000213, PH1000215, PH1000233, PH1000256, PH1000257, PH1000259, PH1000438, PH1000439, PH1000440, PH1000441, PH1000442, PH1000445, PH1000455, PH1000495, PH1000498, PH1000522, PH1000615, PH1000644, PH1000645, PH1000646, PH1000647, PH1000648, PH1000649, PH1000668, PH1000669, PH1000670, PH1000682, PH1000683, PH1000684, PH1000686, PH1000687, PH1000688, PH1000689, PH1000692, PH1000722, PH1000726, PH1000727, PH1000740, PH1000742, PH1000743, PH1000744, PH1000879, PH1000880, PH1000882, PH1000885, PH1000886, PH1000895, PH1000897, PH1000939, PH1000940

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2238-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2238-2019	Class I	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-23

Product code DTQ

K173834Class IIQuantum Pump ConsoleSpectrum Medical , Ltd. / cleared 2018-05-25

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)