Abbott Laboratories Inc. (St Jude Medical) recalls TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Glo…

Recall date

April 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1493-2019

FDA classification

Class II

Brand / firm

Abbott Laboratories Inc. (St Jude Medical)

Sold / distributed

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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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