Class 2 Device Recall Chest Pneumograph NM 3160

• Date Initiated by Firm: April 13, 2020
• Create Date: June 02, 2020
• Recall Status: Terminated on April 14, 2023
• Recall Number: Z-2245-2020
• Recall Event ID: 85560
• 510(K)Number: K080038
• Product Classification: Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
• Product: Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.
• Code Information: Every lot distributed since 1996 with Part #94023
• Recalling Firm/ Manufacturer: Philips North America, LLC; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer Reason for Recall: The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
• FDA Determined Cause: Under Investigation by firm
• Action: In March of 2020 Philips Healthcare sent out an Urgent Medical Device Corrective Action Notice identifying the problem, under what circumstances it can occur, the actions that should be taken by the customer/user to prevent risks for patients/users, and the actions planned by Philips to correct the problem. PRODUCTS: All Pneumograph, chest, NM, 3160 with part #94023 are affected. ACTIONS TO BE TAKEN: Customers/users are asked to review the Notification letter and share with all members of staff who utilize this product. Customers/Users should also retain a copy with the equipment Instructions for Use. The chest pneumograph can continue to be used for monitoring as directed by a physician. 1.Identify all affected chest pneumographs in your facility using the guidelines provided in the HOW TO IDENTIFY AFFECTED PRODUCTS section above.Do not return any product to Philips. 2. Complete and sign the reply form provided on the last page of this letter. 3. Send the completed and signed reply form to Philips via the contact information located on the form. 4. Upon receipt of the reply form, Philips will send you one kit per chest pneumograph in your possession along with instructions for labeling each chest pneumograph. 5. Upon receipt of the kit, follow the included instructions to label each chest pneumograph in your possession. The label to be added identifies the product as containing latex. ACTIONS PLANNED BY PHILIPS: Upon receipt of the completed and signed reply form, Philips will provide one kit per chest pneumograph in each customers possession for the purposes of labeling each affected chest pneumograph. This kit will be provided free of charge.
• Quantity in Commerce: 1075 Units
• Distribution: US Nationwide distribution.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MWI