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FDA · Medical device recall

Getinge 9100-Series Washer Disinfector models: 9120E…

Recall started · FDA enforcement report May 25, 2022 Class II

Reason
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
Status
Ongoing
Distribution
Worldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, SD, TX, VA, WA, WV. (OUS) Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France…

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Enforcement report date
May 25, 2022
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by
Getinge Usa Sales Inc
Product
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Reason
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
Distribution pattern
Worldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, SD, TX, VA, WA, WV. (OUS) Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Kuwait, Libya, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Quantity
127
Codes and lots
UDI Codes: [07340153710023, 07340153710047, 07340153710054, 07340153710061, 9122EW 07340153710030, 07340153710078.] Serial Numbers: WAA088008, WAA088276, WAA089054, WAA089188, WAA089511, WAA091312, WAA092134, WAA097871, WAA098978, WAA087395, WAA087675, WAA087676, WAA088563, WAA088677, WAA088684, WAA088798, WAA088973, WAA090326, WAA090827, WAA090829, WAA091562, WAA092656, WAA092905, WAA093809, WAA094122, WAA094447, WAA095653, WAA095654, WAA095655, WAA096084, WAA096723, WAA096820, WAA099698, WAA100249, WAA100596, WAA100828, WAA102416, WAA102300, WAA102301, WAA086373, WAA088830, WAA089854, WAA089735, WAA089736, WAA090141, WAA090273, WAA090274, WAA091427, WAA093786, WAA094342, WAA095013, WAA095014, WAA096724, WAA098589, WAA099164, WAA098725, WAA100514, WAA100695, WAA100704, WAA100832, WAA101375, WAA100834, WAA101893, WAA076270, WAA085559, WAA086376, WAA086914, WAA086915, WAA088007, WAA088273, WAA088464, WAA088465, WAA087754, WAA088678, WAA088685, WAA088871, WAA088998, WAA089258, WAA089356, WAA089446, WAA089970, WAA089969, WAA090495, WAA090615, WAA090746, WAA091561, WAA091184, WAA091560, WAA091563, WAA091564, WAA091869, WAA091870, WAA091873, WAA091868, WAA092136, WAA091872, WAA092904, WAA093646, WAA093882, WAA093967, WAA094123, WAA094202, WAA094284, WAA094285, WAA094286, WAA094617, WAA094601, WAA095421, WAA096425, WAA096427, WAA096428, WAA097298, WAA098056, WAA099694, WAA099450, WAA099451, WAA099695, WAA099697, WAA100127, WAA100826, WAA100827, WAA100830, WAA101342, WAA101894, WAA103173, WAA088274, WAA093968
Recall started
April 1, 2022
Voluntary or mandated
Voluntary: Firm initiated
Device type
Disinfector, Medical Devices
Root cause (FDA)
Other
What the company told customers
An Urgent Medical Device Notification was issued 04/01/2022 via FedEx which includes serial numbers for affected devices. Customers are to verify they have an affected device and submit the attached Response Form. Distributors are to forward notification on to customers. Getinge service technicians will contact customers to schedule corrective actions. You can continue to use the Getinge Series 9100E-series Washer Disinfector with G1 control systems until the corrective action is performed, there are no precautionary actions necessary. Contact your Getinge representative with questions or for Technical Support call (888) 943-8872 (options 4,2,1), Monday through Friday, 8:00 a.m. - 6:00 p.m EST, or email techsupportIC.us@getinge.com.
Recall number
Z-1078-2022

What this record is about

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A generic icon of the kind of thing the record is aboutA simplified icon of the kind of thing the record is about and the phrases of the record's own text beside it.1 The record: Getinge 9100-Series Washer Disinfector…2 In the record's words:3 Only the kind of thing is drawn4 The record's own words are below“This can lead to installation failure modes and hazardoussituations.”GETINGE 9100-SERIES…

“Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.”Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW., FDA enforcement report, 2022-05-25. The caption is the record's own words.

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FDA device name: Disinfector, Medical Devices

Distributed in (FDA's record): Arizona California Colorado Connecticut District of Columbia Florida Georgia Idaho Illinois Indiana Kentucky Louisiana Maryland Massachusetts Michigan Minnesota Mississippi Missouri Nebraska Nevada New Jersey New York North Carolina North Dakota Ohio Oklahoma Pennsylvania Puerto Rico South Carolina South Dakota Texas Virginia Washington West Virginia

This recall among the others

  • FDA's enforcement report came 54 days after the firm started the recall. For half of the 888 FDA medical device recall events reported in 2022 with a start date, it took 54 days or fewer (by year).
  • Getinge Usa Sales: 1 other recall or notice on this site in the three years before this one (from May 26, 2019).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-1078-2022. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record
FDA recall record Z-1078-2022, May 25, 2022. "Getinge 9100-Series Washer Disinfector models: 9120E." PlainRecords, https://plainrecords.com/recall/device/z-1078-2022/ (as of the day it was built).

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