RegWardenFDA facility compliance records
Company

Z-SYSTEMS AG

1 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 1 recalls1’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2013-05-16
    Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Z-SYSTEMS AG — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10024995-z-systems-ag/

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