The Recall Desk
ModerateFDA (Devices)·Z-2079-2012·Announced 2012-08-01

Getinge 9100-Series Washer Disinfectors Recalled for Ground Fault Breaker Error

Getinge USA Inc is voluntarily recalling 8 large capacity washer disinfectors due to a production error in the ground fault breaker.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary precautionary recall based on a production error in a component (ground fault breaker) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Getinge USA Inc is voluntarily correcting Getinge brand large capacity, floor loading jet spray washer disinfectors, specifically the Electrically Heated 9100-Series. The affected models are Getinge 9120, 9122, 9125, and 9128. These devices are used for mechanical washing, intermediate level thermal disinfection, and drying of hospital case carts, sterilization containers, and other medical equipment.

The recall is based on a report from the ground fault breaker manufacturer regarding a production error. The affected units were manufactured between May 4, 2009, and September 26, 2011. A total of 8 washers are involved in this recall.

The affected units were distributed worldwide, including in the United States (Maryland, Indiana, New Mexico, Massachusetts, Texas, and Kansas) and Canada. Specific serial numbers for the affected units are W50024258, W50024259, W50026573, W50025790, W50017381, W50020296, W50028138, and W50020952. Users should check their serial numbers to determine if their unit is affected.

The recalled product

Product
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model
Manufacturer
Getinge USA Inc
Affected units
8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Serial numbers: W50024258
  • W50024259
  • W50026573
  • W50025790
  • W50017381
  • W50020296
  • W50028138
  • W50020952

Distribution

Distributed in 5 states:

Same manufacturer · Getinge USA Inc

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