FDAClass IIOctober 31, 2018

Aptio Rack Input Module recall

APTIO RACK INPUT MODULE

Why was Aptio Rack Input Module recalled?

The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

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?

Siemens Material Numbers: 10703037, 10711144; UDI: 00630414594477

Product
APTIO RACK INPUT MODULE
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
441 Aptio Automation Modules
Distribution
The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.
Recall date
October 31, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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