Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCA
FDA device recall Z-0001-2008 · posted 2007-11-03 · Terminated
Recall details
- Recalling firm
- Bio-Logic Systems Corp
- Reason for recall
- Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.
- Action taken
- Bio-logic sent a Safety Alert letters dated 7/26/07 to the affected customers, warning them that using the pole to transport the cart may cause the weld at the base of the pole to weaken, causing it to break. As a precaution to ensure customer safety, the accounts were instructed to place the enclosed red sticker on the pole, below the tightening knob. An Instruction sheet is enclosed . The warning label reads: "Caution: Do not use as a handle to move cart. Always lower camera when transporting. Avoid sudden stops or collisions." The accounts were requested to complete and return an enclosed reply sheet acknowledging the receipt of the letter and the placement of the warning labels on the poles. Any questions were directed to Customer Support at 1-800-332-3114.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GWQ
- Quantity affected
- 311 units
- Distribution
- Worldwide Distribution -- USA and China, Egypt, Hong Kong, Israel, Malaysia and Saudi Arabia
- Date initiated
- 2007-07-26
- Date posted
- 2007-11-03
- Date terminated
- 2009-08-12
- Location
- Mundelein, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CEEGRAPH/SLEEPSCAN NETLINK TRAVELER (K052066) | Bio-Logic Systems Corp. | 2005-08-26 |