CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report
Cardiovascular Monitoring Device accessory recalled
Philips North America is recalling Cardiovascular Monitoring Device accessory, distributed nationwide in the US. The recall was initiated on 13 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2244-2020
- FDA event ID
- 85560
- Recalling firm
- Philips North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2020
- FDA classified
- 2 Jun 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 13 Apr 2020 | Recall initiated by company | |
| 2 Jun 2020 | Classified by FDA | +50 days |
| 10 Jun 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Which lots are affected?
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).
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85560This product is part of a recall event; the main page for the event is Magnetic Resonance Imaging Diagnostic Device accessory recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Magnetic Resonance Imaging Diagnostic Device accessory recalled | Philips North America | Foreign Material | Nationwide |
More recalls from Philips North America
All 531| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel recalled | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Cardiac Workstation recalled by Philips North America | Philips North America | Labeling Errors | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |