Skip to content

Aptio Automation Storage and Retrieval Module (SRM) recallZ-2091-2023 · Siemens Healthcare Diagnostics, Inc. · initiated May 16, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the conditions listed below occur within a few milliseconds timeframe of each other: - The SRM module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the SRM module buffer - There is divert gate malfunction and a narrow timing window Only in this specific scenario, Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without a unique error message being generated. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the pending test orders (not yet performed) on Tube B.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm sent a recall letter dated 05/16/2026 to consignees notifying them of the firmware issue presenting with this recall event. Consignees are asked to conduct visual checks of the device's gates at the buffer lane entry daily to ensure there are no obstructions that prevent the correct activation and movement of the divert, the divert looks intact, and the position of the divert is aligned to the profiles when it is diverting a tube without any missing or partial blocking of the carrier. If the visual check does not pass, contact your local technical support for assistance before using the impacted system. Until a service visit to upgrade the firmware of affected devices can be conducted, consignees are asked to maintain awareness of the provided recall notice and conduct daily recommended actions. Consignees are asked to complete and return the provided response form within 7 days of recall notification. Completed forms are to be emailed to [email protected] or faxed to (312)274-7795. Customers with any questions are asked to contact their local Siemens Healthineers Customer Care Center or technical support representative.

Recall details

Recall number
Z-2091-2023
Status
Open, Classified
Initiated by the company
May 16, 2023
Posted by the FDA
Jul 5, 2023
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
83 units
Product code
JJE
FDA submissions
K043546
Distribution
Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IL, KY, LA, MA, MD, MI, MS, MT, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, & WV. The countries of Australia, Brazil, Canada, China, France, Germany, Greece, Italy, Portugal, Saudi Arabia, Spain, Sweden, & United Kingdom.

Product description

Aptio Automation Storage and Retrieval Module (SRM)

Code information (models, lots, serial numbers)

Model No. 10713762 and 10715227; UDI-DI: 00630414596754; All units with software versions prior to 38.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page