Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 The Harmony LA/LED Monitor Arm Adapter is an accessory to the Har
FDA device recall Z-1886-2011 · posted 2011-04-05 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- The arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter
- Action taken
- Steris Corporation sent an Urgent Field Correction Notice letter dated February 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Steris representative would contact customers to arrange for replacement of the product. For questions regarding the firms visit to their facility, customers were instructed to contact Steris Field Service Dispatch at 1-800-333-8828. For any questions regarding this matter call 440-392-7705.
- Root cause
- Other
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 14 Units
- Distribution
- Worldwide Distribution - USA including CO, IL, IN, MO, NC, NV, NY and OH and the countrries of Canada, China, and Australia.
- Date initiated
- 2011-02-18
- Date posted
- 2011-04-05
- Date terminated
- 2013-03-13
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HARMONY LED-1 SURGICAL LIGHTING SYSTEM (K072072) | STERIS Corporation | 2007-10-05 |
| AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM (K013242) | STERIS Corporation | 2001-12-13 |