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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91178

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 18, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mobius Imaging, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1

Z-0344-2023
Recall number
Z-0344-2023
Initiated
November 18, 2022
Classification
Class II
Status
Terminated
Recalling firm
Mobius Imaging, LLC
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.

Code information

UDI-DI 00869346000200 Serial Numbers AIRO-0124, AIRO-0145, AIRO-0288

Distribution pattern

Domestic distribution to consignees in Colorado, Tennessee, and Utah.