Z-1700-2020Class II

Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM...

Name: Z-1700-2020 Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM...
Creator: Abbott
Published: 2020-02-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-02-28 / Terminated / root cause: software

FDA source

Abbott began a recall of Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming... on 2020-02-28. FDA classified it as Class II and gives the reason as "Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be...". 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-1700-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-28
Posted: 2020-04-10
Terminated: 2024-04-18
Recalling firm: Abbott Medical
Product: Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: On 02/28/2020, the frim sent all US consignees an "IMPORTANT MEDICAL DEVICE CORRECTION" letter via USPS three to five-day ground service. The customer notification informed customer that they had recently deployed a Patient Care System (PCS) programmer software that contained an anomaly that may result in specific programming changes not being stored in the device. The Recalling Firm explained that when using the affected programmer software to make certain programming changes, the changes may appear to have been successfully programmed but the device could remain at previously programmed settings. This issue can occur only if changes to tachycardia therapy Tilt or Waveform (monophasic/biphasic) settings are made and therapy energy value are modified from nominal using the new programmer software. The customer notification also informs customer of Patient Management Recommendations: The Recalling Firm has developed an updated programmer software version which will correct this issue. This solution does not present additional risks to patients and no intervention is needed for patients. The Recalling Firm will update the programmer software in the coming days. For any questions contact your representative or Technical Support at 1-800-722-3774 (U.S.).
Quantity in commerce: Software Version 24.6.1 installed into 4733 programmers
Distribution: U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees associated to ICDs that were interrogated from January 22, 2020 to February 6, 2020.
Product codes and lots: Software Version: 24.6.1 Model: 3650, GTIN: 05414734500661 Model: 3330, GTIN: 05414734509725 For affected serial number of programmers see Attachment B.1 Programmers For models of ICDs interrogated by affected programmers see Attachment B.2 Devices.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1700-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1700-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-10

Product code NIK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)