Date Initiated by Firm | April 22, 2021 |
Create Date | May 21, 2021 |
Recall Status1 |
Terminated 3 on May 31, 2024 |
Recall Number | Z-1672-2021 |
Recall Event ID |
87749 |
Product Classification |
System, measurement, blood-pressure, non-invasive - Product Code DXN
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Product | GS777 Wall Transformer
Model: 77710
Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings. |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
Welch Allyn Inc 4341 State Street Rd Skaneateles Falls NY 13153-5300
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For Additional Information Contact | Howard Karesh 315-685-4100 |
Manufacturer Reason for Recall | Potential Risk of fluid ingress to the power supplies,
resulting in risk of an internal electrical short and possible electrical shock |
FDA Determined Cause 2 | Device Design |
Action | Welch Allyn, Inc. (a Hill-Rom Company) issued Customer Medical Device Correction letter ( FSCA-identifier: MOD1329) mailed (with signature service) on April 22, 2021(with signature service) via third Party.
The letter states reason for recall, health risk and risk mitigations until the updated Instructions for Use (IFU) becomes available.
To minimize risk of potential electrical shock be sure to follow these cleaning recommendations:
When Cleaning is performed:
1. Unplug the power supply from the outlet.
2. Ensure the cleaning cloth is not soaking (not dripping or over saturated) with cleaning fluid.
3. Apply minimal pressure on wipe when cleaning; avoid wiping gap areas identified on adapter plug as these areas are most susceptible to liquid ingress.
4. Ensure the power supply and power cord are dry before plugging into electrical outlet.
5. Hold the sides of the power supply when plugging into electrical outlet as pictured below. Avoid contact with bottom of the power supply where cleaning fluid is mostly likely to have accumulated
The customer will be instructed to sign acknowledgement form to confirm receipt and return to a dedicated email address.
Distributors will be asked to forward to their end users. They can request an electronic copy of the FSN and response form to share with end users until updated IFU becomes available. Distributors will be provided instruction on communication with their end users once response form is received.
Consignees of new sales will receive the Field Safety Notice until the IFU is updated. This will be done by pulling updated consignee lists monthly and providing any new consignees with the customer letter.
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Quantity in Commerce | 789682 |
Distribution | Worldwide - US Nationwide distribution
Foreign:
Afghanistan
Albania
Algeria
American Samoa
Argentina
Australia
Austria
Azerbaijan
Bahamas (the)
Bahrain
Bangladesh
Barbados
Belgium
Bermuda
Bhutan
Bolivia (Plurinational State of)
Botswana
Brazil
Brunei Darussalam
Bulgaria
Cameroon
Canada
Chad
Chile
China
Colombia
Congo (the Democratic Republic of the)
Congo (the)
Costa Rica
Croatia
Cyprus
Czechia
Denmark
Dominican Republic (the)
Ecuador
Egypt
El Salvador
Estonia
Eswatini
Finland
France
French Polynesia
Georgia
Germany
Ghana
Greece
Guam
Guatemala
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran (Islamic Republic of)
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kenya
Korea (the Republic of)
Kuwait
Lao People's Democratic Republic (the)
Latvia
Lebanon
Lesotho
Libya
Luxembourg
Malaysia
Maldives
Malta
Mexico
Mozambique
Myanmar
Namibia
Nepal
Netherlands (the)
New Zealand
Nicaragua
Nigeria
Northern Mariana Islands (the)
Norway
Oman
Pakistan
Panama
Paraguay
Peru
Philippines (the)
Poland
Portugal
Puerto Rico
Qatar
R¿union
Romania
Russian Federation (the)
Saudi Arabia
Senegal
Serbia
Singapore
Slovenia
South Africa
Spain
Sri Lanka
Sweden
Switzerland
Taiwan (Province of China)
Thailand
Trinidad and Tobago
Tunisia
Turkey
Uganda
Ukraine
United Arab Emirates (the)
United Kingdom
Venezuela (Bolivarian Republic of)
Viet Nam |
Total Product Life Cycle | TPLC Device Report |
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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.
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