FDAClass IIAugust 29, 2018

DigitalDiagnost Release 3 recall

DigitalDiagnost Release 3 (Stitching Patient Support) 712025

Why was DigitalDiagnost Release 3 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: 510694/SN12000240 510890/SN12000259 511451/SN13000066 510334/SN12000218 511346/SN13000008 511214/SN12000353 12000161 510089/SN12000293

Product
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
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