OFFICIAL-SOURCE RECALL · AUSTRALIA
Getinge Assured Batch Monitoring PCD Recall: Classification Class III Reason for the Action
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Getinge Assured Batch Monitoring PCD
- Manufacturer
- See official notice
- Lot number
- numbers, Monitoring
- Batch number
- numbers, Monitoring
- Model number
- PL589
- Serial number / range
- 54043A
- Date code
- dates
- Expiration date
- dates
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Classification Class III Reason for the Action Getinge has identified a problem with certain Getinge Assured Batch Monitoring PCD units, where the required O-ring was not installed during manufacture following a customer complaint. The root cause was identified as a combination of a supplier production process failure and an internal quality inspection error. Failure of the device, due to the missing O-ring, may state sterilisation cycle was not completed and may require re-sterilisation, which may disrupt workflow. This could result in delay of goods and, as such, delay of procedure; should this occur, it is anticipated that any procedural delays would be prior to administration of anaesthesia. Instructions for Customers/Users Customers are to: - Examine their inventory immediately to identify any affected Getinge Assured Batch Monitoring PCD units listed in this Product Recall and remove them from use. - Arrange return of the
Hazard
Classification Class III Reason for the Action Getinge has identified a problem with certain Getinge Assured Batch Monitoring PCD units, where the required O-ring was not installed during manufacture following a customer complaint. The root cause was identified as a combination of a supplier production process failure and an internal quality inspection error. Failure of the device, due to the missing O-ring, may state sterilisation cycle was not completed and may require re-sterilisation, which may disrupt workflow. This could result in delay of goods and, as such, delay of procedure; should this occur, it is anticipated that any procedural delays would be prior to administration of anaesthesia. Instructions for Customers/Users Customers are to: - Examine their inventory immediately to identify any affected Getinge Assured Batch Monitoring PCD units listed in this Product Recall and remove them from use. - Arrange return of the
Official recall notice
Getinge Assured Batch Monitoring PCD
Agency: Therapeutic Goods Administration
Official publication date: November 4, 2025
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