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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93544

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

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Event summary

Timeline bucket
November 17, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Draegerwerk Ag & Co. Kgaa

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

Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)

Z-0971-2024
Recall number
Z-0971-2024
Initiated
November 17, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Draegerwerk Ag & Co. Kgaa
Quantity
50 imported to US, not distributed to end users

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.

Code information

UDI-DI: 04048675556176 (Atlan A350) 04048675556183 (Atlan A350 XL) Lots: ASSH-0220 ASSH-0221 ASSH-0222 ASSH-0223 ASSH-0224 ASSH-0225 ASSH-0226 ASSH-0227 ASSH-0228 ASSH-0229 ASSH-0230 ASSH-0231 ASSH-0232 ASSH-0233 ASSH-0234 ASSH-0235 ASSH-0236 ASSH-0237 ASSH-0238 ASSH-0239 ASSH-0240 ASSH-0241 ASSH-0242 ASSH-0243 ASSH-0244 ASSH-0245 ASSH-0246 ASSH-0247 ASSH-0248 ASSH-0249 ASSH-0250 ASSH-0251 ASSH-0252 ASSH-0253 ASSH-0254 ASSL-0347 ASSL-0347 ASSL-0349 ASSL-0350 ASSL-0351 ASSL-0352 ASSL-0353 ASSL-0354 ASSL-0355 ASSL-0356 ASSL-0357 ASSL-0358 ASSL-0359 ASSL-0360 ASSL-0361

Distribution pattern

No devices were distributed to end-users (customers) in the US. All devices are currently under the direct control of Draeger, Inc.