Skip to content

Adac Laboratories

Country not established

Devices
88
FDA recalls
6

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Adac Laboratories makes

Adac Laboratories manufactures medical imaging systems and software, including nuclear medicine imaging computers, digital processing systems, and cardiology modules. Their product portfolio also encompasses quantitative blood pool SPECT systems, imaging systems, and additional software solutions.

The company's devices are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) registry. Adac Laboratories is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue88

Newest first, rows 1-50 of 88

Search and filter all 88 devices
Skip device list

Rows 1-50 of 88

Showing 1-50 of 88

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 6 recalls initiated by Adac Laboratories, initiated on 2004-03-03. By recorded status: 6 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2004

    • 3 Mar 2004 Z-0911-04 Unclassified (pre-2012) Terminated A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe. Distribution: The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China,…
      Full distribution text The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.
      Submission number: K032724
    • 3 Mar 2004 Z-0912-04 Unclassified (pre-2012) Terminated A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe. Distribution: The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China,…
      Full distribution text The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.
    • 3 Mar 2004 Z-0913-04 Unclassified (pre-2012) Terminated A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe. Distribution: The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China,…
      Full distribution text The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.
    • 3 Mar 2004 Z-0914-04 Unclassified (pre-2012) Terminated A software defect, relating to the motorized wedge functionality when using an Elekta linear accelerator, can result in incorrect dose delivery to the patient. Also, dose delivery in the wrong location may occur when using a Elekta Leksell headframe. Distribution: The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China,…
      Full distribution text The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.
    • 3 Mar 2004 Z-0915-04 Unclassified (pre-2012) Terminated Dose delivery in the wrong location may occur when using a Elekta Leksell headframe. Distribution: The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China,…
      Full distribution text The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.
    • 3 Mar 2004 Z-0916-04 Unclassified (pre-2012) Terminated Dose delivery in the wrong location may occur when using a Elekta Leksell headframe. Distribution: The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China,…
      Full distribution text The recalled products were shipped to consignees located nationwide the United States and in Australia, Canada, China, and Korea.

Frequently asked questions

How many devices does Adac Laboratories have in the registry?

The registry currently lists 88 devices for Adac Laboratories. Devices recorded under merged duplicate company entries are counted once.

Which registries list Adac Laboratories's devices?

Among its 50 most recently registered devices, Adac Laboratories has devices listed in FDA 510(k) (50 devices).

What risk classes do Adac Laboratories's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Adac Laboratories's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Adac Laboratories?

FDA recall records list 6 recalls initiated by Adac Laboratories, the most recent initiated on 3 Mar 2004. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Adac Laboratories in the registry?

The most recently registered devices listed for Adac Laboratories include JETSTREAM WORKSPACE, ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM, DPS-33000 NUCLEAR MEDICINE IMAGING COMPUTER and ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE.

Generated automatically from registry data and not verified by a human reviewer.