Recall Z-0808-2022— GE Healthcare, LLC

Name: FDA recall Z-0808-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-28

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-01-28. It names one FDA 510(k) clearance: K162012. Product: GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.. Reason: If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-01-28
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K162012 — CARESCAPE Central Station V2GE Healthcare·cleared 2016-09-15

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

GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.

Reason for recall

If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.

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