FDAClass IIAugust 29, 2018

DigitalDiagnost Release 3.1 recall

DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

Why was DigitalDiagnost Release 3.1 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: SN13000495 SN14000058 SN13000463 SN14000051 SN14000214 SN14000047 SN14000077 SN13000484 SN14000082 SN14000163 SN14000133 SN14000134 SN14000134 SN14000023 SN14000041

Product
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
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