# FDA recall Z-1700-2020

> **Abbott** · Class II · device recall initiated 2020-02-28.

## 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.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1700-2020
- **Recalling firm:** Abbott
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-28
- **Report date:** 2020-04-22
- **Termination date:** 2024-04-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sylmar, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1700-2020

## Citation

> AI Analytics. FDA recall Z-1700-2020. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1700-2020. Source: US FDA. Licensed CC0.

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