FDAClass IIMarch 15, 2017

Apollo DRF recall

Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

Why was Apollo DRF recalled?

Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.

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?

08090531 09090591 10040680 15051450 11020798

Product
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Recalling firm
Villa Sistemi Medicali S.P.A.
Quantity
65 devices in total
Distribution
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, PA, Puerto Rico, TN, TX, UT, and W.I
Recall date
March 15, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls