FDAClass IIAugust 29, 2018

DigitalDiagnost 4.1 Flex / Value recall

DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028

Why was DigitalDiagnost 4.1 Flex / Value recalled?

The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

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?

Serial Numbers: SN16000197 SN15000288 SN16000234 SN16000008 SN15000304 SN15000283 SN15000174 SN15000225 SN16000124 SN16000023 550162 SN15000350 SN16000092 SN15000379 SN16000283 SN16000104 SN15000173

Product
DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028
Recalling firm
Philips Medical Systems Gmbh, DMC
Distribution
US Nationwide; International to 66 countries
Recall date
August 29, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls