Recall Z-2238-2019— Spectrum Medical Ltd.

Name: FDA recall Z-2238-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-29

Class I · Terminated

Class I FDA medical device recall by Spectrum Medical Ltd., initiated 2019-05-29, terminated 2020-08-21. It names one FDA 510(k) clearance: K173834. Product: Quantum Pump Console. Reason: Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use..

Recalling firm: Spectrum Medical Ltd.
Classification: Class I
Status: Terminated
Initiated: 2019-05-29
Terminated: 2020-08-21
Firm location: Gloucester, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K173834 — Quantum Pump ConsoleSpectrum Medical , Ltd.·cleared 2018-05-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Quantum Pump Console

Reason for recall

Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.