Class 2 Device Recall

• Date Initiated by Firm: September 19, 2019
• Create Date: February 04, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0985-2020
• Recall Event ID: 83869
• 510(K)Number: K140535
• Product Classification: System, Monitoring, Perinatal - Product Code HGM
• Product: Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
• Code Information: All serial numbers sold between 01/21/2015 - 04/30/2019
• Recalling Firm/ Manufacturer: Pacific Medical Group Inc. ; 212 Avenida Fabricante; San Clemente CA 92672-7538
• For Additional Information Contact: 800-449-5328
• Manufacturer Reason for Recall: Fetal transducers distributed in advance of receiving 510(k) and international clearances.
• FDA Determined Cause: No Marketing Application
• Action: On 09/19/19, Urgent Medical Device Recall notices were emailed to customers informing them of the following possible failures associated with the post market events: - Fluid damage/intrusion, solder cracks, component failure. - Damaged membrane or cracked case. - Internal short from usage, broken connector from misuse. - Broken leads, loose coil. - Loose crystal from failure of adhesive, internal short or improper grounding. - Miscalibration of the device/waveform. - Overheat of device. Malfunction of the device is likely to be recognized easily because the device will not function properly without intact components. If wave forms are not capturing the clinical data including fetal heart rate, oxygen saturation, patient's temperature or uterine activity, the device should not be used. Immediate actions to be taken by the Customer/User: - Inspect the device before each use to observe for any signs of device damage including cracked case, broken leads, loose coils, or damaged components and immediately remove the device from clinical service. - If any fluid intrusion is noted, remove the device from service immediately. - Any signs that the device is overheating should be recognized as a potential serious issue and should not be used and/or removed from the patient immediately. - If waveforms are not capturing on the monitor or there is artifact, this may be due to miscalibration of the device or a component malfunction. Remove the device from service. You may continue to utilize the affected devices as the recalling firm reasonably believes use of, exposure to, the affected products is not likely to cause adverse health consequences. Complete and return the customer acknowledgement form to the recalling firm. If you have subsequently resold or distributed the affected product, please ensure that this information is provided to your customer(s). Customers with additional questions or complaints are encouraged to call (800) 449-5328.
• Quantity in Commerce: 225
• Distribution: U.S.: IN, AZ, IL, HI, AK, AR, CA, FL, GA, IA, ID, LA, MA, NC, NE, NM, NY, OK, PA, TN, TX, UT, VA, WA, WV, NV, KY, CO, ME, ND, OH, SC, WI, AL, OR, DC, DE, MD, MI, MN, MO, MT, MS, NJ, NH. O.U.S. (Foreign): CA, CO, FR, GB, IT, MX, UAE
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HGM and Original Applicant = PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH