PlainRecalls
LowClass IIITerminated

FDA Devices recall · Reported August 26, 2015

Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.

Recall #
Z-2419-2015
Affected scope
20 devices
Initiated
June 26, 2015
Compiled from official public sources by the editorial team.
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Getinge Disinfection Ab recalled Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Mode… - a low-severity action.

Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Mode… was recalled by Getinge Disinfection Ab in August 26, 2015. Reason: Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote acce…. Check the official notice for the remedy. Verify recall #Z-2419-2015 with the FDA Devices before acting.

The recall

Getinge Disinfection Ab issued this low-severity FDA Devices recall-Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote acce….

Low
severity level
20 units
affected scope
Class III
classification
August 26, 2015
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2419-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2419-2015) was formally reported on August 26, 2015, with the manufacturer initiating the action on June 26, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Getinge Disinfection Ab is listed as the recalling firm, operating out of Vaxjo. Federal records list the affected scope as 20 devices.

The documented reason for this recall is: Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network. Distribution data in the federal record shows the product reached: Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

20 devices

Related Recalls

6

3 from same agency

Product description

Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.

Reason for recall

Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number Z-2419-2015
Date reported August 26, 2015
Date initiated June 26, 2015
Recalling firm Getinge Disinfection Ab
Firm location Vaxjo
Affected scope 20 devices
Distribution Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

20 devices units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2419-2015) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.. Recalled by Getinge Disinfection Ab. Units affected: 20 devices.
Why was this product recalled?
Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 26, 2015. Severity: Low. Recall number: Z-2419-2015.
Where was the recalled product distributed?
Distribution: Distributed in CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, and WA..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2419-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 26, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.