FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions Diagnostics: Direct Water feed Kit, Catalog#10373222
- Recall number
- Z-1661-2015
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Product
- Direct Water feed Kit, Catalog#10373222
- Status
- Terminated
- Initiated
- 2015-03-05
- Posted
- 2015-05-23
- Terminated
- 2018-01-16
- Reason
- The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
- Root cause
- Nonconforming Material/Component
- Action
- Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.
- Quantity
- 15 bottles
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Direct Water Feed Kit - Product Code/Catalog #10373222
- 510(k) numbers
- ["K970227"]
- PMA numbers
- ["P010053S007"]
- Product code
- JJE
- Firm FEI
- 1000122204
- Firm city
- Flanders
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28