STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K
FDA device recall Z-0869-2012 · posted 2012-01-25 · Terminated
Recall details
- Recalling firm
- Steris Corporation Hopkins Facility
- Reason for recall
- Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these criteriae may lead to cycle aborts by the SYSTEM 1E Liquid Chemical Sterilant Processing System. The firm intends to perform a software field correction which
- Action taken
- The firm, STERIS Corp. prepared an "URGENT VOLUNTARY FIELD CORRECTION NOTICE" letter dated December 8, 2011. The firm intends to send the letter to its customers upon STERIS' receipt of 510(k) clearance from FDA. The letter includes a description of the Product-SYSTEM Liquid Chemical Sterilant Processing System, problem and actions taken. The customers were instructed to in case of an incomplete or cancelled cycle, reprocess devices in the cycle following the directions in the Operator manual. The letter also states that STERIS Corporation will install updated software on the affected system, and will be providing the customers with a new Operator Manual reflecting the revised wording resulting from the installation of the new software. For further information or if they have any questions regarding the firms visit to their facility, contact STERIS Field Service Dispatch at 1-800-333-8828. If you have questions regarding this matter, contact Director Low Temperature Sterilization, at 440-392-7455.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MED
- Quantity affected
- 3,882 units were distributed
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.
- Date initiated
- 2011-12-07
- Date posted
- 2012-01-25
- Date terminated
- 2014-05-13
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM (K102462) | STERIS Corporation | 2010-09-21 |
| SYSTEM 1.5 STERILE PROCESSING SYSTEM (K090036) | STERIS Corporation | 2010-04-05 |