CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report
Aptio Rack Output Module recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Aptio Rack Output Module, distributed in 38 states. The recall was initiated on 14 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0214-2019
- FDA event ID
- 81047
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Aug 2018
- FDA classified
- 23 Oct 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Aug 2018 | Recall initiated by company | |
| 23 Oct 2018 | Classified by FDA | +70 days |
| 31 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Product as listed by the FDA
APTIO RACK OUTPUT MODULE
Where it was distributed
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.
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Is Aptio Rack Output Module recalled?
Yes. Siemens Healthcare Diagnostics recalled Aptio Rack Output Module on 14 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0214-2019.
Why was it recalled?
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Which lots are affected?
Siemens Material Numbers: 10715432, 10715434; UDI: 00630414594477
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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