Reported Oct 21, 2020 · Ongoing

Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical…

Getinge Group Logistics America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Getinge Group Logistics America, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094

Is this the product you have?

  • Servo-i Ventilator, Part No. 6487800
  • UDI Code 07325710000823 - Product Usageintended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults
Lot codes and dates
  • Lot 6487800 Serial numbers

    431 of 431 codes

    • 95160
    • 95283
    • 95284
    • 95285
    • 95286
    • 95287
    • 95288
    • 95289
    • 95290
    • 95291
    • 95292
    • 95293
    • 95294
    • 95295
    • 95296
    • 95297
    • 95363
    • 95364
    • 95365
    • 95366
    • 95367
    • 95368
    • 95369
    • 95370
    • 95371
    • 95372
    • 95373
    • 95374
    • 95431
    • 95432
    • 95433
    • 95374
    • 95435
    • 95436
    • 95437
    • 95438
    • 95439
    • 95440
    • 95441
    • 95442
    • 95455
    • 95456
    • 95457
    • 95458
    • 95459
    • 95460
    • 95461
    • 95462
    • 95463
    • 95464
    • 95465
    • 95466
    • 95467
    • 95468
    • 95469
    • 95470
    • 95471
    • 95472
    • 95473
    • 95474
Amount recalled
431 units

Where it was sold

Why it was recalled

A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.