Z-1672-2021Class II

GS777 Wall Transformer Model: 77710

Name: Z-1672-2021 GS777 Wall Transformer Model: 77710
Creator: Welch Allyn Inc
Published: 2021-04-22
License: https://open.fda.gov/license/

Welch Allyn Inc / initiated 2021-04-22 / Terminated / root cause: design

FDA source

Welch Allyn Inc began a recall of GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings on 2021-04-22. FDA classified it as Class II and gives the reason as "Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1672-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-22
Posted: 2021-05-21
Terminated: 2024-05-31
Recalling firm: Welch Allyn Inc
Product: GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings.
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Root cause tag: design
FDA root cause: 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. .
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
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1672-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1672-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-21
Z-1673-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-21

Product code DXN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)