International Medical Devices Database

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

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Type of Event
Recall
Event ID
58416
Event Risk Class
II
Event Initiated Date
2010-04-29
Event Country
Canada
Event Source
HC
Notes / Alerts

Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
Extra notes in the data
Reason
The cp200 has stat electrocardiograph (ecg) mode that generates an ecg without an associated patient identifier and the auto ecg mode where the user can override the required patient identifier.

Device

CP 200

Model / Serial
Model Catalog: CP2-1E1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2AS-1E1-L (Lot serial: SEE MANUFACTURER.); Model Catalog: CP2-1F1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2A-1E1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2A-1F1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2AC-1E1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2AC-1F1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2AS-1E1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2AS-1F1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2C-1E1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2C-1F1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2S-1E1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2S-1F1 (Lot serial: SOFTWARE VERSION 2.4); Model Catalog: CP2SC-1F1 (Lot serial: SEE MANUFACTURER.); Model Catalog: CP2SC-1E1 (Lot serial: SEE MANUFACTURER.); Model Catalog: CP2S-1F1 (Lot serial: SEE MANUFACTURER.); Model Catalog: CP2S-1E1 (Lot serial: SEE MANUFACTURER.); Model Catal
Product Description
WELCH ALLYN CP 200 ELECTROCARDIOGRAPH
Manufacturer
WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED

Manufacturer Address
MISSISSAUGA
Manufacturer Parent Company (2017)
Hill-Rom Holdings, Inc
Source
HC

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Recall of CP 200

What is this?

Device

CP 200

Manufacturer

WELCH ALLYN CANADA LIMITED