Recall Z-0985-2020— Pacific Medical Group Inc.

Name: FDA recall Z-0985-2020
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: K140535. Product: Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250. 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

K140535 — PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50Philips Medizin Systeme Boblingen GmbH·cleared 2014-11-25

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

Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250

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.