Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90648

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

Open FDA event record

Event summary

Timeline bucket
July 21, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Getinge Usa Sales Inc

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

Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)

Z-1568-2022
Recall number
Z-1568-2022
Initiated
July 21, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
US 102 units; OUS 13750 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk

Code information

UDI-DI: 07325710003114 Serial Numbers: 10558 12349 20122 20135 20148 21704 23177 23169 23430 23652 23749 23762 10561 12350 20123 20136 20150 21705 23178 23171 23431 23653 23750 23763 10567 12351 20124 20137 20151 21706 23179 23188 23432 23654 23751 23857 10569 12352 20125 20138 20153 21707 23180 23375 23429 23655 23752 23858 10573 12353 20126 20139 20155 22206 23183 23376 23536 23656 23753 23973 10575 12354 20127 20140 20149 22551 23185 23377 23537 23657 23754 23974 10579 12355 20128 20141 20152 22552 23187 23422 23538 23658 23755 23975 10580 20117 20129 20142 20156 22865 23294 23423 23539 23659 23756 24013 10585 20116 20130 20143 20157 23181 23164 23424 23563 23660 23757 24014 10586 20118 20131 20144 20300 23176 23165 23425 23551 23661 23758 24015 12287 20119 20132 20145 20529 23184 23166 23426 23552 23697 23759 24016 12347 20120 20133 20146 21702 23128 23167 23427 23650 23698 23760 24017 12348 20121 20134 20147 21703 23175 23168 23428 23651 23699 23761

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel (IL), Japan (JP), Mexico (MX), Pakistan (PK), Saudi Arabia (SA), South Africa (ZA), South Korea (KR), Switzerland (CH), Taiwan (TW), Turkey (TR), and United Arab Emirates (AE).

Field note

Send feedback

We'll only use this to respond to your feedback.