FDA Device recall Z-1949-2015
INSTRUMENT ARM DRAPE, IS4000, 20 PACK
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of INSTRUMENT ARM DRAPE, IS4000, 20 PACK by Intuitive Surgical, citing field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the V….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1949-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-16 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Reason
Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the Vision Cart touchscreen - Missing reload error.
Identifiers
| code_info | Manufacturing lot numbers: 470015-05, 470015-06. System numbers: SK0194 SK0312 SK0182 SK0195 SK0313 SK0241 SK03…Manufacturing lot numbers: 470015-05, 470015-06. System numbers: SK0194 SK0312 SK0182 SK0195 SK0313 SK0241 SK0321 SK0131 SK0117 SK0149 SK0068 SK0197 SK0329 SK0185 SK0183 SK0253 SK0142 SK0141 SK0078 SK0128 SK0224 SK0192 SK0381 SK0085 SK0086 SK0247 SK0109 SK0088 SK0199 SK0200 SK0201 SK0215 SK0223 SK0336 SK0164 SK0256 SK0202 SK0214 SK0089 SK0165 SK0374 SK0374 SK0124 SK0260 SK0323 SK0252 SK0319 SK0327 SK0373 SK0335 SK0129 SK0184 SK0229 SK0110 SK0111 SK0350 SK0351 SK0136 SK0132 SK0190 SK0290 SK0158 SK0207 SK0341 SK0246 SK0226 SK0187 SK0232 SK0303 SK0328 SK0330 SK0315 SK0334 SK0204 SK0248 SK0344 SK0322 SK0219 SK0353 SK0222 SK0154 SK0318 SK0217 SK0196 SK0221 SK0172 SK0218 SK0220 SK0379 SK0213 SK0108 SK0177 SK0179 SK0101 SK0170 SK0233 SK0309 SK0234 SK0235 SK0105 SK0104 SD0002 SK0240 SK0360 SK0203 SK0091 SK0106 SK0206 SK0326 SK0294 SK0291 SK0237 SK0293 SK0238 SK0292 SK0272 SK027 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1949-2015%22
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