Z-1085-2022Class II

DxM 1040 MicroScan WalkAway Instrument REF B1018-440

Name: Z-1085-2022 DxM 1040 MicroScan WalkAway Instrument REF B1018-440
Creator: Beckman Coulter Inc.
Published: 2019-10-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-10-21 / Open, Classified

FDA source

Beckman Coulter Inc. began a recall of DxM 1040 MicroScan WalkAway Instrument REF B1018-440 on 2019-10-21. FDA classified it as Class II and gives the reason as "WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1085-2022
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-21
Posted: 2022-05-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DxM 1040 MicroScan WalkAway Instrument REF B1018-440
Product code: LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Reason for recall: WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
FDA root cause: Mixed-up of materials/components
Action: During the week of 10/21/2019, Beckman Coulter sent an "URGENT MEDICAL DEVICE RECALL" Letter via e-mail and postal mail informing customers that some WalkAway instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1A (ampere) current rating rather than the correct current rating at 10A. Customers are instructed to: If the component fails and and the WalkAway suffers a power loss, user should: --Contact the Customer Support Center. If in the United States call 1-800-677-7226. If outside the United States, contact their local Beckman Coulter Representive. --Determine if the customer knows how long the WalkAway has been without power. If the time is unknown or greater than 2 hours, then panels should be reset, or an alternate test method should be used. -- If within 2 hours window the instrument will maintain the environmental conditions. Depending on the panel type, the user has the option to read the panels manually, on an autoSCAN-4 (if available) or reset the panels. - If the component remains functional, a Beckman Coulter Field Service Representative will contact the user to schedule an onsite visit. During the visit the representative will inspect the suspect instrument and if the incorrect component is found, will replace the component with the correct one rated at 10A. -Complete and return Customer Response Form to Beckman Coulter, Inc. 1584 Enterprise Blvd. West Sacramento, CA 95691 Attn: Quality Systems & Compliance Fax number: 916-374-2119 Email address: [email protected] For questions, contact: -via website, http://www.beckmancoulter.com/customersupport/support -via phone, call 1-800-677-7226 in the United States, -If outside the United States, contact the local Beckman Coulter Representative.
Quantity in commerce: 40 systems
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, and Washington. The countries of Belgium, Brazil, Colombia, Germany, Hong Kong, Indonesia, Italy, Japan, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, United Arab Emirates, Vietnam and Yemen.
Product codes and lots: Catalog Number: B1018-440 UDI-DI Code: 15099590690885 Serial Numbers: 44010026 44010027 44010028 44010029 44010030 44010031 44010032 44010033 44010035 44010036 44010037 44010038 44010040 44010041 44010042 44010043 44010044 44010045 44010046 44010047 44010048 44010049 44010050 44010051 44010052 44010053 44010054 44010055 44010056 44010057 44010058 44010059 44010060 44010061 44010063 44010064 44010065 44010066 44010067 44010068

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1085-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1083-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-13
Z-1084-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-13
Z-1085-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-13
Z-1086-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-13
Z-1087-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-13
Z-1088-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-13

Product code LRG

K911400Class IIWalkaway Tm 40Baxter Healthcare Corp / cleared 1991-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)