FDAClass IISeptember 6, 2023

RayCare software recall: Software Issue

RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling…

Why was RayCare software recalled?

An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product name (build number) UDI-DI RayCare 5A (5.0.0.60390) 0735000201039620210524 RayCare 5A SP1 (5.0.1.60052) 0735000201046420220305 RayCare 5B SP1 (5.1.1.60246) 0735000201053220220316 RayCare 5B SP2 (5.1.2.60028) 0735000201062420220613 RayCare 5B SP3 (5.1.3.60023) 0735000201069320221027 RayCare 6A (6.0.0.60553) 0735000201056320220617

Product
RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling…
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
1 install
Distribution
US Nationwide distribution in the state of TN.
Recall date
September 6, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls