Z-2244-2020Class II

Cardiovascular Monitoring Device accessory -

Name: Z-2244-2020 Cardiovascular Monitoring Device accessory -
Creator: Philips North America, LLC
Published: 2020-04-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-04-13 / Terminated / root cause: labeling and UDI

FDA source

Philips North America, LLC began a recall of Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or... on 2020-04-13. FDA classified it as Class II and gives the reason as "The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2244-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-13
Posted: 2020-06-02
Terminated: 2023-04-14
Recalling firm: Philips North America LLC
Product: Cardiovascular Monitoring 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.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Root cause tag: labeling and UDI
FDA root 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: 2360 Units
Distribution: US Nationwide distribution.
Product codes and lots: Every lot distributed since 1996 with model/catalog number: BSM43-0752-05 (Part number 0600-1005 is on the device label, but 0600-1005 is the non-sellable part of the sellable Toshiba part number BSM43-0752-05).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2244-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2244-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02
Z-2245-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-02

Product code MWI

K090785Class IIMRI Compatible Patient Monitoring System, Model 865214Invivo Corp. / cleared 2009-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)