AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO
FDA device recall Z-1561-2015 · posted 2015-04-30 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay.
- Action taken
- On 3/9/2015, the firm sent Urgent Field Correction Notices, to their customers. The letter identified the affected product and gave a description of the problem. The letter states that the control software is being revised to ensure the utility shutdown feature will not interrupt an ongoing processing cycle. STERIS Field Representatives will contact customers to schedule installation of the new control board on affected units. Customers may direct questions regarding the issue to STERIS Customer Service at 1-800-548-4873; Marie LaFrance, Product Manager, at 440-392-7648, or their local sales representative.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- FLE
- Quantity affected
- 701 units
- Distribution
- Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, I, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR,
- Date initiated
- 2015-02-19
- Date posted
- 2015-04-30
- Date terminated
- 2016-01-20
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMSCO CHIMERON MEDIUM STEAM STERILIZER (K112055) | STERIS Corporation | 2011-12-16 |
| AMSCO CHIMERON SMALL STEAM STERILIZER (K111223) | STERIS Corporation | 2011-09-20 |