Tempus LS recall
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Why was Tempus LS recalled?
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
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?
Device Serial Numbers 7021.002073 and 7021.002074
- Product
- Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
- Recalling firm
- Remote Diagnostic Technologies Ltd.
- Quantity
- 2
- Distribution
- US Nationwide distribution in the states of IL and KS.
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)