Recall Z-0983-2020— Pacific Medical Group Inc.

Name: FDA recall Z-0983-2020
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 Transducer w/wing 5700LAX, FFCM5260. 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 Transducer w/wing 5700LAX, FFCM5260

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.