Atellica IM Humidity Pack recall: Software Issue
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for…
Why was Atellica IM Humidity Pack recalled?
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot 0010
- Product
- Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 2149
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recall date
- March 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)