Z-1850-2014Class II
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting...
STERIS Corporation / initiated 2014-04-04 / Terminated / root cause: design
Steris Corporation began a recall of Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051... on . FDA classified it as Class II and gives the reason as "Potential for the welded seam in affected monitor spring arms to crack and/or break". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1850-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- STERIS Corporation
- Product
- Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.
- Product code
- FSY Light, Surgical, Ceiling Mounted
- Reason for recall
- Potential for the welded seam in affected monitor spring arms to crack and/or break.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- On April 11, 2014 the firm sent Urgent Voluntary Field Correction Notices to their customers.
- Quantity in commerce
- 68 units
- Distribution
- Distribution to US (states: MA, NY, OH, PA & TX) and Canada.
- Product codes and lots
- Model #: YG19051, Serial #'s: 01108340587, 01117338881, 011106337516, 011106337525, 011106337527, 011106337534, 011106337535, 011106337538, 011106337539, 011106337541, 011106337626, 011107338878, 011107338882, 011107338883, 011108340587, 011108340600, 0111073388883 & 011108340600A. Model #: YG19262, Serial #: ART00001 - ART00010, CADS0001 - CADS0015, CBX0001 - CBX0010 & CXSG0008 - CXSG0022.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1850-2014 | Class II | Terminated | Voluntary: Firm initiated |
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