FDA · Medical device recall
ValueLine Mat Platform Model C2230A,B,C… and 4 more products
- Date posted by the FDA
- July 12, 2006
- Status
- Terminated
- Filed by
- Sammons Preston Rolyan
- Reason
- There have been reports of structural failure on the skirt of select tables. The risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.
- Distribution pattern
- Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.
5 products in this recall
ValueLine Mat Platform Model C2230A,B,C…
- Product
- ValueLine Mat Platform Model C2230A,B,C; C922-30A, B,and C; C6904, C6903, C6902, C6901. All tables have the standard platform and the model numbers represent the additional shelves or drawers and the arrangement.
- Quantity
- 561 devices total
- Codes and lots
- Serial number prefixess 2509 throuth 2511.
- Recall started
- Jan. 25, 2006
- Device type
- Plinth
- Root cause (FDA)
- Other
- What the company told customers
- Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
- Recall number
- Z-1207-06
Midland Deluxe Mat Platform- Model C2237A…
- Product
- Midland Deluxe Mat Platform- Model C2237A, B and C
- Quantity
- 8 devices total
- Codes and lots
- Serial number prefixess 2509 throuth 2511
- Recall started
- Jan. 25, 2006
- Device type
- Plinth
- Root cause (FDA)
- Other
- What the company told customers
- Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
- Recall number
- Z-1208-06
Midland Deluxe Mat Platform with Adjustable Backrest Model C5522-30A…
- Product
- Midland Deluxe Mat Platform with Adjustable Backrest Model C5522-30A, B, and C,
- Quantity
- 831 devices total
- Codes and lots
- Serial number prefixess 2509 throuth 2511
- Recall started
- Jan. 25, 2006
- Device type
- Plinth
- Root cause (FDA)
- Other
- What the company told customers
- Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
- Recall number
- Z-1209-06
Midland Space-Saver Mat Platform Model C2236
- Product
- Midland Space-Saver Mat Platform Model C2236
- Quantity
- 74 devices total
- Codes and lots
- Serial number prefixess 2509 throuth 2511
- Recall started
- Jan. 25, 2006
- Device type
- Plinth
- Root cause (FDA)
- Other
- What the company told customers
- Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
- Recall number
- Z-1210-06
ValueLine Space-Saver Folding Mat Platform model C9222-30S…
- Product
- ValueLine Space-Saver Folding Mat Platform model C9222-30S; C2230S
- Quantity
- 23 devices total
- Codes and lots
- Serial number prefixess 2509 throuth 2511
- Recall started
- Jan. 25, 2006
- Device type
- Plinth
- Root cause (FDA)
- Other
- What the company told customers
- Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
- Recall number
- Z-1211-06
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1207-06, Z-1208-06, Z-1209-06, Z-1210-06, Z-1211-06. The agency record governs; check it and the company before acting.