Recall Z-0982-2020— Pacific Medical Group Inc.

Name: FDA recall Z-0982-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-19

Class II · Ongoing

Class II FDA medical device recall by Pacific Medical Group Inc., initiated 2019-09-19. It names one FDA 510(k) clearance: K012718. Product: Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660. Reason: Fetal transducers distributed in advance of receiving 510(k) and international clearances..

Recalling firm: Pacific Medical Group Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-09-19
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K012718 — MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.Ge Medical Systems Information Technologies·cleared 2001-11-13

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

Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660

Reason for recall

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

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