FDAClass IIAugust 29, 2018

DigitalDiagnost recall

DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062

Why was DigitalDiagnost 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: 386786/SN0702512 375366 416255/SN0902004 358322 388667/SN0802105 375367 397229/SN0802250 396838/SN0802365 386108/SN0802044 405687/SN0802469 354125 362438 406156/SN0802537 413697/SN0802634 402853/SN0902012 405889/SN0802629 383385/SN0802011 378827/SN0802021 384013/SN0702495 358017 358496 377925/SN0802060 356953 355621 357888 356956 368431 356963 406016/SN0802476 346522 375370 70700 351321 392504/SN0802182

Product
DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
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