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: SN14000256 SN14000250 SN15000024 SN14000170 SN14000052 SN14000224 SN15000039 SN14000144 SN14000253 SN14000239 SN14000186 SN14000075 SN14000193 SN14000254 SN15000001 SN14000089 SN14000223 SN14000267 SN14000238 SN14000164 SN14000165 SN14000200 SN14000005 SN14000040 SN15000015 SN15000029 SN14000120

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