# FDA recall Z-1493-2019

> **Abbott Laboratories Inc. (St Jude Medical)** · Class II · device recall initiated 2019-04-05.

## Product

TactiSys Quartz Equipment (with software version 1.7)   Model: PN-004 400   Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)

## Reason for recall

In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data.  This may lead to intermittent contact force data to be displayed during the procedure.

## Distribution

US, UNITED KINGDOM, UAE, TURKEY, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA,   SLOVAKIA, SINGAPORE, SERBIA, SAUDIA ARABIA, RUSSIA, ROMANIA,   PORTUGAL, POLAND, PALESTINE, OMAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, LEBANON, JORDAN, JAPAN,   ITALY, ISRAEL, IRELAND, IRAN, GREECE, GERMANY, FRANCE, EL SALVADOR, EGYPT, DENMARK, Czech Republic, CHINA, CANADA, BULGARIA, BELGIUM, AUSTRIA, AUSTRALIA

## Key facts

- **Recall number:** Z-1493-2019
- **Recalling firm:** Abbott Laboratories Inc. (St Jude Medical)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-05
- **Report date:** 2019-06-05
- **Termination date:** 2021-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1493-2019

## Citation

> AI Analytics. FDA recall Z-1493-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1493-2019. Source: US FDA. Licensed CC0.

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